FDA 483 - Specialty Compounding, LLC - September 13, 2013

This FDA Form 483 details observations from an inspection of a firm that prepares various sterile drug products from bulk non-sterile APIs and excipients, which are then either sterilized or aseptically filled.

Key observations include: * **Failure to thoroughly review discrepancies:** The firm failed to review unexplained discrepancies or batch failures to meet specifications, even for distributed batches. * **Sterilization process not validated:** The sterilization process for sterile drug products is not validated. * **Inadequate smoke studies:** Smoke studies are not performed under dynamic conditions in ISO 5 Laminar Flow Hoods used for aseptic processing. * **Insufficient QC review of records:** Drug product production and control records are not reviewed and approved by the quality control unit before batch release or distribution. * **Deficient complaint records:** Complaint records lack investigation findings, follow-up, and essential details like drug product name/strength, lot number, complainant name, nature of complaint, and reply. * **Incomplete batch records:** Batch production and control records do not contain complete information. * **Inappropriate personnel clothing:** Clothing of personnel engaged in drug product processing is not appropriate for their duties. * **Lack of written procedures:** No written procedures exist for production and process controls to assure drug product identity, strength, quality, and purity. Written procedures for equipment cleaning and maintenance are also absent. * **No stability testing program:** There is no