FDA 483 - Pine Pharmacy and Home Care Products Center, Inc. - April 18, 2016

This FDA Form 483 document details observations made during an inspection of Pine Pharmacy and Home Care Products Center, Inc., a sterile drug producer located in Williamsville, NY, from March 30 to April 18, 2016. The inspection revealed several deficiencies in their sterile drug production processes.

**Key Observations:**

1. **Protective Apparel:** Operators' neck areas were not fully covered, exposing skin over the critical ISO 5 laminar flow area during sterile drug processing. Excessive conversation was also observed between operators in the ISO 5 zone. 2. **Environmental Monitoring:** * Work surfaces inside ISO 5 hoods were not tested for microbial contamination daily; monitoring was performed less frequently. * Non-viable particulate monitoring was only performed periodically by an outside vendor. * ISO 7 clean rooms, the ISO 7 anteroom, and unclassified surrounding areas were only monitored for air pressure differentials. 3. **Contamination Prevention (Beta-Lactam Drugs):** No separate facilities existed for processing beta-Lactam injectable drugs (e.g., Ceftazidime), which were processed in the same ISO 5 hood as non-beta-Lactam drugs, posing a contamination risk from potential spills. 4. **Sterilization Process Validation:** The firm had not validated its sterilization process for sterile drug products (e.g., Progesterone in Sesame Oil