FDA 483 - Wellness Pharmacy, Inc. - September 30, 2014

This FDA Form 483 document outlines several significant observations made during an inspection, indicating a lack of adherence to Good Manufacturing Practices (GMP) for drug products, particularly those purporting to be sterile or pyrogen-free.

Key deficiencies include: * **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established, written, or followed. * **Equipment Sanitation:** Equipment and utensils are not sanitized at appropriate intervals, risking contamination that could compromise drug product safety, identity, strength, quality, or purity. * **Pyrogen Testing:** Batches of drug products purporting to be pyrogen-free are not laboratory tested to confirm conformance to pyrogen requirements. * **Personnel Protection:** Protective apparel is not worn as necessary to safeguard drug products from contamination. * **Facility Construction:** Buildings used for manufacturing, processing, packing, or holding drug products lack suitable construction to facilitate cleaning, maintenance, and proper operations. * **Aseptic Processing Environmental Monitoring:** Aseptic processing areas have deficient systems for monitoring environmental conditions. * **Drug Product Release Testing:** Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release. * **Equipment Calibration:** Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance. * **Stability Testing Program:** There is