FDA 483 - The Wellness Center Pharmacy, Inc., dba Designer Drugs - May 28, 2015

This FDA Form 483 document details multiple observations from an inspection, indicating significant deficiencies in the facility's manufacturing and quality control processes for drug products, particularly those purporting to be sterile.

Key violations include: * **Sterilization Process Validation:** Procedures to prevent microbiological contamination lack adequate validation of the sterilization process. * **Personnel Clothing:** Clothing worn by personnel during manufacturing, processing, and packing is inappropriate for their duties. * **Aseptic Processing Area Deficiencies:** * Inadequate system for cleaning and disinfecting equipment to achieve aseptic conditions. * Deficient environmental monitoring system. * Lack of appropriate equipment for air pressure and microorganism control. * Air supply not filtered through high-efficiency particulate air (HEPA) filters under positive pressure. * **Equipment Design and Maintenance:** Equipment is not suitably designed or located to facilitate cleaning and maintenance. * **Calibration:** Instruments, apparatus, and gauges are not calibrated at suitable intervals. * **Product Testing and Release:** * Batches requiring freedom from objectionable microorganisms are not tested appropriately. * Drug products are not tested for conformance to final specifications, identity, and strength of active ingredients prior to release. * **Stability Testing:** No written program exists to assess drug product stability characteristics. * **Laboratory Records:** Laboratory records lack complete data from all necessary tests and assays. * **