FDA 483 - Jeffreys Drug Store - February 09, 2016

The FDA Form 483 documents multiple deficiencies observed during an inspection. The facility manufactures sterile injectable drug products, including Testosterone Cypionate and Testosterone Propionate, Methylcobalamin, and Trimix.

Key violations include: 1. **Lack of Batch Testing:** No potency, sterility, or endotoxin testing is performed for sterile and pyrogen-free injectable products, including Testosterone Cypionate/Propionate (90-day BUD, room temp), Methylcobalamin (30-day BUD, refrigerated), and Trimix (30-day BUD, refrigerated). 2. **Environmental Monitoring Deficiencies:** The environmental and personnel monitoring program for aseptic processing areas is deficient. Personnel monitoring is conducted (b) (4), operator gloves are not sampled daily, and no environmental samples are taken during production of the listed sterile injectables. 3. **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination are not established or followed. Uncovered vials were found in the ISO 6 anteroom, unlabeled vial tips were in the ISO 5 LAF Hood, a trashcan blocked airflow in the ISO 6 anteroom, and dirty plastic separation flaps were observed between the anteroom and cleanroom. No smoke studies have been performed in the ISO 5 area. 4. **Lack of Stability Testing:** No written testing program or stability testing is performed for Testosterone Cypionate/Propionate, Methylcobalamin, or Trimix injectables