FDA 483 - Belmar Pharmacy - June 18, 2015

The FDA Form 483 documents observations from an inspection concerning the manufacturing of sterile drug pellets, including Anastrozole, Testosterone/Anastrozole, Progesterone, Pregnenolone, and DHEA.

Key violations include: 1. **Inadequate Sterilization Process Validation:** The sterilization process for sterile drug pellets has not been validated, and bioburden studies are lacking. 2. **Insufficient Environmental Monitoring:** No environmental microbial monitoring program exists for cleanroom suites (powder, compression, packaging, ante rooms) to ensure the sterility of compounded pellets. 3. **Documentation Gaps:** A gap in pressure differential data from the Ante room to the unclassified lab space was noted from April 13, 2015, to May 30, 2015. 4. **Lack of Batch Testing for Sterility/Endotoxin:** Routine sterility and/or endotoxin testing is not conducted for each batch of sterile drug pellets prior to release, and method suitability for these tests is absent. The firm's own Sterilization, Testing and Validation Policy and Procedure (P&P 10.090, Rev. 1) is not followed regarding pellet sampling and testing for potency, identification, endotoxins, and sterility. 5. **Inadequate Release Testing:** Not every compounded lot of sterile drug pellets is tested for identification and/or potency prior to release. Potency method suitability is