PQ Pharmacy, LLC – 715795

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient:

Recipient Name

Hale N. Dimetry

Recipient Title

President

PQ Pharmacy, LLC

15215 Technology Drive
Brooksville, FL 34604-0690
United States

Issuing Office: Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER
WL # 715795

October 10, 2025

Dear Mr. Dimetry:

You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1 on October 29, 2020, and most recently on November 26, 2024. From March 25, 2025, to April 4, 2025, an FDA investigator inspected your facility, PQ Pharmacy, LLC, located at 15215 Technology Drive, Brooksville, FL 34604. During the inspection, the investigator noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. In addition, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.

FDA issued a Form FDA 483 to your facility on April 4, 2025. FDA acknowledges receipt of your facility’s response, dated April 7, 2025. Based on this inspection, it appears you produced drugs that violate the FDCA.

A. Compounded Drug Products under the FDCA

Under section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.2

An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.

In addition, for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]).

Furthermore, for a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)” (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (b)(5)]).

B. Failure to Meet the Conditions of Section 503B

During the inspection, the FDA investigator collected evidence indicating that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigator collected evidence indicating that:
1. Some of your facility’s drug products, such as Prednisolone/Moxifloxacin HCl/Bromfenac PF Sterile Ophthalmic Solution and Prednisolone/Moxifloxacin HCl PF Sterile Ophthalmic Solution, did not include the established name of the drug.

2. Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, CFR (or any successor regulations).3 Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not include the following information in the definition of what constitutes a “serious” adverse event: “Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.” (21 CFR 310.305(b)).

Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.

Specific violations are described below.

C. Violations of the FDCA

Adulterated Drug Products

The FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that:

1. An operator rested their arms on the work surface of the hood during aseptic production. This practice may introduce contamination into the ISO (b)(4) work area.

2. Operators conducted aseptic manipulations in an area where the movement of “first air” in the ISO (b)(4) area was disrupted by operator manipulations, including the failure to limit unnecessary movement and make mindful, slow, deliberate movements within the ISO (b)(4) laminar flow hoods and within the ISO (b)(4) cleanroom suite.

3. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO (b)(4) area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

The FDA investigator also noted CGMP violations at your facility that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:

1. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

2. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

3. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

4. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance, Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.

Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.

Unapproved New Drug Products

You do not have any FDA-approved applications on file for drug products that you compound.4 Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 331(d)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.

Misbranded Drug Products

You compound drug products that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.5 The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. Further, it is also a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.

D. Corrective Actions

We have reviewed your facility’s response to the Form FDA 483. Some of your corrective actions appear adequate; however, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:

1. You did not provide scientific justification for the selection of (b)(4) intensity to conduct visual inspection for all sterile products.

2. You did not provide training records and personnel qualification records for procedure S203005.3 Qualification of Personnel for Particulate and Defect Inspection Activities.

Some of your corrective actions appear deficient:

1. Regarding your failure to conduct hold time studies, we note that you have provided methods, such as media fill runs, to mitigate certain risks; however, these measures alone are insufficient. A hold time study remains necessary to evaluate container closures of the bulk holding material, testing of the bulk material being held prior to further processing, potential risk associated with sterility, contamination, product degradation, adsorption, or absorption. Furthermore, you failed to establish adequate written procedures for production and process controls, including but not limited to the following:

a. Hold time studies to justify your (b)(4)-day holding of bulk product.

b. Hold time studies to include the impact of an additional (b)(4) step, particularly in cases where such steps are used to extend the bulk hold period beyond the initial (b)(4)-days.

c. Process validation, to include your (b)(4) step following detection of particulates or to provide a scientific study justifying this step. Moreover, you failed to define when an investigation is warranted in the event a product requires (b)(4). For example, your standard operating procedures do not mandate a root cause investigation in cases of (b)(4) failure or particulate observation beyond initiating a deviation. Additionally, your classification of deviations, such as “Critical Deviation,” does not include the definition for (b)(4) resulting from (b)(4) failures (b)(4).

2. Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. More specifically, you failed to expand your investigations into other products using the same lots of affected material (i.e. bulk bags, syringes, or (b)(4)). Although you state that a review was conducted, the deviation report does not include a list of the specific lots that were assessed. Relying solely on trending data is not sufficient to justify the scope of an investigation.

a. Regarding the (b)(4) of the bulk solution bag, your response fails to clarify whether your (b)(4) process has been validated for repeat (b)(4) procedures. While your firm has identified the likely root cause of deviation DEV2024072 as intrinsic to the interior of the bulk bag, your response does not demonstrate that you have conducted adequate analysis beyond verifying expiration dates. Furthermore, there is no evidence that you examined other products manufactured using the same lot of bulk bags that produced the contaminated material, nor did you conduct additional review of retained samples that could provide valuable insight into the scope of this issue. Moreover, you did not investigate the integrity of the bags’ material nor conduct further investigation including communicating with the manufacturer. In addition, particulate testing appears to have been conducted only after the repeated (b)(4), which raises concerns that the nature and extent of the contamination were not being appropriately characterized.

b. Regarding your failure to follow-up on the root cause determination of DEV2024075, numerous critical deficiencies remain unaddressed and require comprehensive corrective and preventative actions. Your investigation does not include an adequate root cause analysis as you failed to review other products using the same lot of syringes, conduct any review of retained samples, or provide identification and characterization of the particulates to determine how they differed from the 19 rejects identified during 100% visual inspection. Additionally, your response does not address whether you investigated the integrity of the syringes themselves or notified the syringe manufacturer or distributor of this potential component-related issue.

c. You failed to follow-up your root cause determination of DEV2023007 related to the sterile (b)(4). Additionally, you did not conduct process validation for the change involving the flushing and discarding of the first (b)(4) or (b)(4) mL of product (depending on the product). You also conducted no further investigation into the (b)(4) issue, including communication with the manufacturer.

d. Your conclusion that post-bulk fill contamination was addressed through (b)(4) does not identify the original source of the contamination.

Additionally, you provided no assessment or strategy to prevent further (b)(4) contamination from reoccurring.

e. You did not provide a risk analysis of the products produced during the observed poor aseptic practices, nor was this analysis extended to other drug products produced on the same days. Disposition was also not provided for the following products, including whether they were released or distributed:

3. Your smoke studies remain inadequate to demonstrate proper unidirectional airflow within the ISO (b)(4) area. While we acknowledge that your smoke studies now include dynamic studies mimicking the operations of capping and crimping, these studies reveal airflow deficiencies that could compromise aseptic operations. Specifically, video 4 (b)(4) Static shows from time 0:59 to 1:37 the smoke arching past multiple rows of vials as it exits the front of the hood, indicating disrupted laminar flow that could transport contaminants across the work surface. Additionally, multiple objects such as the sampling plates and the sampler, are placed in front of the ventilation at the back of the hood, creating physical barriers that disrupt the intended unidirectional airflow pattern.

In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]

Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.

FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.

E. Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.

All correspondence should refer to the Warning Letter Number above (# 715795) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.

Sincerely,
/S/

F. Gail Bormel, JD, RPh
Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research

________________________

1 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).

2 We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.

3 For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf.

4 The specific products made by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.

5 Your compounded drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).

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