Carie Boyd Pharmaceuticals LLC – FDA 483, Jun 21, 2024

This FDA Form 483 document details observations from an inspection of an outsourcing facility. The inspection revealed several deficiencies related to sterile drug product manufacturing and quality control.

Key violations include: 1. **Lack of Microbiological Contamination Prevention Procedures:** Procedures to prevent microbiological contamination of sterile drug products are not established. 2. **Inadequate Discrepancy Investigations:** There is a failure to thoroughly review unexplained discrepancies, even for distributed batches. 3. **Insufficient Environmental Controls:** Equipment for adequate humidity and temperature control, appropriate for drug product manufacturing, processing, packing, or holding, is not provided. 4. **Deficient Equipment Cleaning and Maintenance:** Procedures for cleaning and maintaining equipment are inadequate, specifically regarding the protection of clean equipment from contamination prior to use. 5. **Non-Sterile Containers and Closures:** Drug product containers and closures were not adequately cleaned, sterilized, or processed to remove pyrogenic properties, failing to ensure their suitability for intended use. 6. **Non-Compliant Product Labeling:** Labels for the outsourcing facility’s drug products do not include all information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act.

These observations indicate significant issues with the facility's quality system, manufacturing processes, environmental controls, and product labeling, potentially impacting the sterility, quality, and regulatory compliance of its drug products.