by Pill Pals | Oct 29, 2024 | News
Please note: Extended Use Dates for Baxter products needed during Hurricane Helene recovery efforts can be found here. Based on stability data provided by the manufacturers and reviewed by FDA, the following extended use dates are supported for specific lot numbers...
by Pill Pals | Oct 28, 2024 | News
Summary Company Announcement Date: October 28, 2024 FDA Publish Date: October 28, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description [email protected] Company Name: One Roof, LLC. Brand Name: Product Description:...
by Pill Pals | Oct 27, 2024 | News
Summary Company Announcement Date: October 25, 2024 FDA Publish Date: October 26, 2024 Product Type: Food & Beverages Fish Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Listeria monocytogens Company Name: Acme...
by Pill Pals | Oct 27, 2024 | News
Summary Company Announcement Date: October 26, 2024 FDA Publish Date: October 26, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Listeria monocytogenes Company Name: Fresh...
by Pill Pals | Oct 26, 2024 | News
Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: The Food and Drug Administration has used income tax information from the Internal Revenue Service in the past to aid the agency’s investigative efforts. POLICY: The policy of the agency...
by Pill Pals | Oct 26, 2024 | News
Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: A district compliance officer has inquired if a domestic distributor can take advantage of the immunity offered by 21 USC 333(c)(2) by obtaining from a foreign manufacturer, or his resident...
by Pill Pals | Oct 26, 2024 | News
Issued by: Guidance Issuing Office Office of Regulatory Affairs Compliance Policy Guide 270.100 Final Container Labels – Allergenic Extracts Containing Glycerin; Reporting Changes is obsolete and was withdrawn on 1/30/2020. Issued: 7/19/76Revised: 10/1/80,...
by Pill Pals | Oct 26, 2024 | News
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other...
by Pill Pals | Oct 26, 2024 | News
Issued by: Guidance Issuing Office Office of Regulatory Affairs Compliance Policy Guide Sec. 230.120- Human Blood and Blood Products As Drugs is obsolete and was withdrawn on 1/30/2020. Issued 6/17/74Revised 10/1/80Withdrawn: 1/30/2020 Submit Comments Submit...