Delivery Method: Via Email Reference #: 320-25-101 Product: Animal & Veterinary
Drugs Recipient:
Recipient Name
Mr. Ronald E. Sutton
Recipient Title
President & Owner
Chromatography Institute of America dba Compounder’s International Analytical Laboratory
4760 Castleton Way, Suite A
Castle Rock, CO 80109
United States
rsutton@compounderslab.com Issuing Office: Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
Center for Veterinary Medicine
United States
Warning Letter 320-25-101
August 20, 2025
Dear Mr. Sutton:
The United States Food and Drug Administration (FDA) inspected your contract testing laboratory, Chromatography Institute of America dba Compounder’s International Analytical Laboratory, FEI 3012069146, at 4760 Castleton Way, Suite A, Castle Rock, Colorado, from February 24 to March 5, 2025.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (APIs).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drugs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your March 21, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigators observed specific violations and deviations including but not limited to the following:
1. Lack of adequate laboratory control mechanisms
Your firm conducts chemical and microbiological testing of APIs, drug products compounded by outsourcing facilities registered under section 503B of the FD&C Act, and finished drug products for human and animal use. Records and information collected during the inspection demonstrate that you use the same methods and procedures whether you are testing APIs, drug products compounded by outsourcing facilities registered under section 503B of the FD&C Act, or finished drug products for human and animal use.
You lacked adequate controls to ensure the reliability of your microbiological testing results. For example, you documented sterility failures for several samples prepared in a (b)(4) media lot, but you were unable to show that you performed growth promotion testing on this lot before use. In your investigations into these sterility failures, you noted “false positives” with this lot, but you did not include appropriate negative controls corresponding to this lot in your tests and lacked sufficient evidence to support your “false positives” statement. Moreover, after obtaining a failing sterility test result, you repeated the test on a fraction of the original sample amount, which is not in accordance with USP <71> and is an unacceptable practice.
In your response, you state that you rely on your manufacturer’s certificates of analysis to establish media suitability. You indicate that you perform growth promotion testing (b)(4) and that moving forward, you commit to performing growth promotion testing on (b)(4) media lot. Additionally, you assert that you will revise your procedures to note that you will perform retesting of a failed sample, provided that sufficient sample quantity remains after initial testing. You also assert that you follow all aspects of USP <71> “as best as is possible.”
Your response is inadequate because you did not include a comparability analysis of your sterility test method and USP <71> method, to show that your method is equivalent despite the deviations from USP <71> requirements, such as growth promotion testing, negative controls, and sterility retest sample amounts. You also did not include any documentary evidence to support your assertions about random testing and updated procedures.
In response to this letter, provide:
- A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to evaluate and remediate the effectiveness of your laboratory system.
- A comprehensive assessment and remediation plan for your sterility testing procedure to ensure that it satisfies all requirements specified in USP <71>. Include:
o Instructions for how you determine which of your method kits ((b)(4)) purchased from third-party suppliers are suitable for sterility testing of your laboratory samples.
o A requirement that each media lot used in the preparation of sterility samples on a given day will include an appropriate negative control.
o Requirements for appropriate sample amounts needed for a sterility retest. - A remediation plan for qualification of your suppliers of growth media. Include a commitment to perform growth promotion testing on all incoming media lots used for microbial and sterility testing, to verify their suitability for use.
2. Lack of adequate investigations
Your investigations into multiple failed sterility test results were inadequate. In 2024, you had nine drug product sterility test failures, for which your investigation concluded that the probable root cause was “technician error – environmental contamination.” However, your root cause was not supported by the environmental monitoring data on the dates when the failing sterility samples were prepared. You did not recover any microorganisms on settle plates from your ISO 7 sterility suite, on ISO 5 “compounding aseptic isolators” where your sterility samples are prepared, or on contact plates used for monitoring of personnel who prepared the sterility samples. You subsequently performed a new analysis on the drug product samples, and you recorded the passing results.
In your response, you indicate that you initiated corrective and preventive actions (CAPA), which included the retraining of technicians and their dismissal upon repeated infractions, review of your sterility procedures and cleaning agents, and the frequency of cleaning the sterility suite.
Your response is inadequate. You initially identified the potential root cause “technician error – environmental contamination” in 2024, and you continued to note this root cause in several subsequent sterility out-of-specification (OOS) investigations, without identifying and implementing the appropriate CAPA from these investigations to prevent similar future errors.
In response to this letter, provide:
- A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for U.S. products for the last three years from the initial date of inspection, and a report summarizing the findings of the analysis, including the following for each OOS:
o Determine whether the scientific justification and the evidence relating to the invalidated OOS result conclusively or inconclusively demonstrate causative laboratory error.
o For investigations that conclusively establish laboratory root cause, provide the rationale, and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation. - A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include but should not be limited to addressing the following:
o Quality unit oversight of laboratory investigations
o Identification of adverse laboratory control trends
o Resolution of causes of laboratory variation
o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified
o Adequate scoping of each investigation and its CAPA
o Revised OOS investigation procedures with these and other remediations - A comprehensive assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include but should not be limited to significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure that all phases of investigations are appropriately conducted.
3. Lack of adequate Quality Unit oversight
Your Quality Unit (QU) failed to exercise adequate oversight over your contract testing operations. For example, your QU failed to ensure:
- Establishment of restricted access and appropriate controls on computerized systems to prevent any potential alteration or deletion of laboratory data.
- Implementation of an effective document control system for issuance, tracking, and reconciliation of CGMP documents used for laboratory testing and analysis.
- Review and approval of an uncontrolled document, “Sample Prep Tips and Tricks,” used by laboratory staff for preparation of analytical samples.
In your response you state that moving forward, you will create individual logins on your computers, and you are looking into installing technology with audit trail capability. Further, you state that you will create templates for your forms and bind them into a book. You also commit to placing the unapproved sample preparation document, “Sample Prep Tips and Tricks,” into your controlled document system.
Your response is inadequate because it does not include a comprehensive assessment into the vulnerabilities in your computerized systems that may have affected data integrity, nor do you explain how binding the templates into a book will remedy the deficiencies in your documentation control practices. Your response does not indicate whether your sample preparation protocols have been validated, to ensure that sample preparation is consistent and suitable for analysis. Finally, your response lacks details on how your QU will oversee CAPA implementation and evaluate their effectiveness.
In response to this letter, provide:
- A comprehensive assessment and remediation plan to ensure that your QU is given the authority and resources to function effectively. The assessment should also include but should not be limited to:
o A determination of whether procedures used by your firm are robust and appropriate.
o Provisions for QU oversight throughout your operations, to evaluate adherence to appropriate practices.
o A complete and final review of each batch and its related information before the QU makes a decision concerning its disposition.
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products. - A comprehensive, independent assessment and CAPA plan for computer system security and integrity. Include a report that identifies design and control vulnerabilities and provides appropriate remediations for each of your laboratory and manufacturing computer systems. This should include but should not be limited to:
Compounder’s International Analytical Laboratory, Castle Rock 3012069146 page 5
o A list of all hardware that includes all equipment, both stand-alone and network, in your laboratory.
o A list of all software configurations (both equipment software and (b)(4)) and versions, details concerning all user privileges, and oversight responsibilities for your computerized systems. Regarding user privileges, specify user roles and associated user privileges (including the specific permissions allowed for anyone who has administrative rights) for all staff who have access to the laboratory and manufacturing computer systems, with their organizational affiliation and title. Also describe how you will ensure that staff are not given administrative rights or other permissions that may compromise data retention or reliability.
o System security provisions, including but not limited to whether unique usernames/passwords are always used and their confidentiality is safeguarded.
o Detailed procedures for robust use and review of audit trail data, and the current status of audit trail implementation for each of your systems.
o Technological improvements to increase the integration of data generated through electronic systems from stand-alone equipment (for example, balances, pH meters, water-content testing equipment) into the (b)(4) network.
o A detailed summary of your procedural updates and associated training, including but not limited to system security control to prevent unauthorized access, and to ensure appropriate user role assignments, secondary review of all analyses, and other system controls. - A comprehensive evaluation of your document “Sample Prep Tips and Tricks” and how it is used to determine the preparation method for analytical samples. Describe how you verify the suitability of the sample preparation method, and if you document the method in a sample preparation protocol that is reviewed and approved by the QU.
Ineffective Quality System
Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. In addition to the lack of effective management oversight of your laboratory operations, we found that your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.
See FDA’s guidance for industry Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download for help in implementing an adequate Quality Unit (QU) in your laboratory operations to meet the requirements of CGMP.
Responsibilities of a Contract Testing Lab
FDA considers contractors as extensions of the manufacturer’s own facility. Your failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs you test for your clients. It is essential that you understand your responsibility to operate in full compliance with CGMP, and that you inform all your customers of any OOS results or significant problems encountered during the testing of these drugs.
We also have concerns about the validity and integrity of the data you provided to outsourcing facilities registered under section 503B of the FD&C Act.
Drug Testing Ceased
During the FDA inspection, you communicated your intention to shut down your contract testing laboratory and to cease operations. However, several statements made in your responses to the FDA Form 483 observations conflict with this declaration.
In response to this letter, clarify the current operational status of your contract testing laboratory. If you plan to sell your laboratory, provide the name and address of the acquiring party.
If you plan to resume contract laboratory testing operations regulated under the FD&C Act, notify this office before resuming your drug testing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure that your firm can comply with ongoing CGMP. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.
Note that remediating these CGMP violations will be necessary if Compounder’s International Analytical Laboratory, a successor, or an acquirer resumes drug testing operations at this site.
CGMP Consultant Recommended
If your firm intends to resume testing drugs for the U.S. market, you should engage a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP.
Conclusion
The violations and deviations cited in this letter are not intended to be an all-inclusive list of violations and deviations that exist at your facility. You are responsible for investigating and determining the causes of any violations and deviations and for preventing their recurrence or the occurrence of other violations and deviations.
Correct any violations and deviations promptly. Failure to address this matter promptly and adequately may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations and deviations may also prevent other federal agencies from awarding contracts.
Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations and deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations and deviations.
This letter notifies you of our findings and provides you with an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration while we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012069146 and address it “ATTN: Christopher Keating.”
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
/S/
Johnetta Walters, Ph.D.
Acting Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Cc:
Nancy G. Sutton
Vice President & Owner
Email: nsutton@compounderslab.com
