Aurolife Pharma, LLC, Madan Reddy, Director, Hyderabad 500084 Telangana, India
During our investigation of your manufacturing facility our investigators observed:
1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.
2. Your firm failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair.
3. Your firm failed to establish and follow written procedures for cleaning and maintenance of equipment.
4. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess
Family Pharmacy of Statesville, Inc., Joshua Eudy, CEO Family Pharmacy of Statesville, Statesville, NC 28625
Based on our inspection it appears that you are violating Section 503 A of the FDCA in that
1. Receipt of valid prescriptions for individually identified patients
In addition, your firm prepared, packed, or held under insanitary conditions drug products:
2. Your firm did not use as sporicidal agent in ISO 5 Areas
3. Your firm reused bottles for use in the ISO 5 area without assurance that the bottles remained sterile after multiple uses.
4. Your firm handled hazardous drugs without providing adequate cleaning of work surfaces.
5. Material flows directly from an unclassified area into a room in which sterile production occurs via a pass-through window.
6. Your firm produced drug products with materials that had not been verified to assure that they did not contribute to endotoxin contamination that may be objectionable given the product's intended use.
7. Your firm failed to confirm that the quality of water was suitable for its intended use in the production of non-sterile drug products.
8. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
More - too numerous to mention
Nartex Laboratorios Homeopaticos S.A. de C.V., Eduardo Acosta CEO, Torreon, Coah.Mexico During our inspection, our investigator observed specific violations and deviations including, but not limited to, the following.
1. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess.
2. Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality