u/kc567897

WARNING LETTER
WL # 717972
December 1, 2025
Dear Ms. Rana:
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 September 7, 2024, and most recently on January 11, 2025. From May 12, 2025, to May 15, 2025, FDA investigators inspected your facility, Apothecary Pharma, LLC located at 1913 Evans Road, Cary, NC 27513. During the inspection, the investigators 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 investigators 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 May 15, 2025. FDA acknowledges receipt of your facility’s response, dated June 9, 2025, and related attachments received July 17, 2025. FDA acknowledges that your firm ceased sterile drug production as of May 12, 2025, and notified FDA of an intent to resume sterile drug production on August 1, 2025. Based on this inspection, it appears you produced drugs that violate the FDCA.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apothecary-pharma-llc-717972-12012025?utm_source=chatgpt.com

I know people say you don’t get apothecary, you will get PGRx but PGRX never been evaluated by the FDA.