FDA 483 - Town and Country Compounding and Consultation Services, LLC - August 22, 2016

This FDA Form 483 details multiple significant violations at a drug manufacturing facility.

**Facility and Operations:** The facility produces various drug products, including sterile injectables like Sermorelin/GHRP-6, HCG, Glutathione, Atropine, Morphine-Clonidine-Baclofen Intrathecal, Penicillin G, and Anastrozole. Operations involve compounding, lyophilization, and sterile filling.

**Violations and Observations:**

* **Failure to Reject Non-Conforming Products:** * Twelve vials of Sermorelin/GHRP-6 Lot # 07172016@1 were dispensed despite a confirmed sterility failure and without final review/approval. * HCG Lot # 05272016@17, Glutathione Lot # 120414AS, and Atropine Lot # 063015DS had potency values outside specifications (74.3%, 82.86%, 91.70% respectively). HCG was dispensed. Glutathione and Atropine formulations were subsequently dispensed in other lots without ensuring potency within specifications for Beyond Use Dating. * **Deficient Microbiological Contamination Prevention:** * Poor aseptic practices observed: incomplete sanitization of supplies entering ISO 6/7 rooms, and no disinfection of supplies entering the ISO 5 laminar