FDA 483 - Nature's Pharmacy & Compounding Center - November 22, 2013

During an FDA inspection conducted from November 12-22, 2013, Nature's Pharmacy & Compounding Center, a producer of sterile drugs, received a Form FDA 483 citing numerous significant deficiencies. The observations primarily highlighted critical failures in quality control and aseptic processing, indicating a lack of adherence to manufacturing standards. Key violations included the absence of essential laboratory controls; specifically, the firm failed to perform assay, sterility, or endotoxin testing on any of the sterile injectable or ophthalmic drug products it manufactured and distributed. Furthermore, the sterilization processes used were not validated, with no media fills or process simulations ever conducted. The facility also exhibited severe shortcomings in its environmental monitoring program, lacking microbial air, surface, and personnel monitoring, and failing to verify aseptic area air supply through smoke studies or continuous pressure monitoring. Additional issues involved inadequate cleaning and disinfection practices, the use of inappropriate non-sterile garments by personnel during aseptic operations, and a complete absence of a written program for stability testing to support product expiration dates. Crucially, the firm lacked established written procedures for its quality control unit, encompassing sterile drug processing, testing, and quality assurance. These observations collectively require the company to implement comprehensive corrective actions to ensure the safety, quality, and purity of its sterile drug products.