Ionia Pharmacy – FDA 483, Mar 6, 2015

This FDA Form 483 document outlines several deficiencies observed during an inspection. The facility's aseptic processing areas were found to have a deficient system for monitoring environmental conditions. Equipment and utensils were not cleaned at appropriate intervals, potentially leading to contamination that could alter drug product safety, identity, strength, quality, or purity. Procedures designed to prevent microbiological contamination of sterile drug products were not established and followed, and protective apparel was not worn as necessary to protect drug products from contamination.

Container closure systems were inadequate, failing to provide sufficient protection against foreseeable external factors during storage and use that could cause deterioration or contamination. Each batch of drug product purporting to be pyrogen-free was not laboratory tested for conformance. Additionally, each lot of a component liable to objectionable microbiological contamination was not subjected to microbiological tests before use.

Testing and release of drug products for distribution did not include appropriate laboratory determination of satisfactory conformance to final specifications prior to release. Results of stability testing were not used in determining appropriate storage conditions. Finally, batch production and control records lacked complete information relating to the production and control of each batch. These observations indicate significant issues across environmental monitoring, equipment sanitation, aseptic procedures, product protection, quality control testing, stability data utilization, and record-keeping.