FDA WARNING_LETTER - Cross Brands Contract Filling, LLC - June 10, 2019

On December 17, 2019, the FDA issued a Warning Letter to Cross-Brands Manufacturing LLC following an inspection from June 6-10, 2019, at their Rockledge, Florida facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to verify component identity and validate supplier analyses (21 CFR 211.84(d)(1) and (2)):** The firm did not test raw materials for OTC sunscreens and topical salicylic acid products, relying solely on vendor Certificates of Analysis (COA) without validation. 2. **Inadequate Quality Control Unit (21 CFR 211.22):** The Quality Unit (QU) lacked sufficient oversight, written procedures, and failed to ensure complete batch and laboratory records. The QU also misrepresented microbiological test results (e.g., for *Staphylococcus aureus* and *Pseudomonas aeruginosa*) on COAs released to customers. 3. **Failure to conduct microbiological testing of components (21 CFR 211.84(d)(6)):** The firm lacked a monitoring program for the microbiological quality of water used in topical drug products.

The FDA also identified significant data integrity issues, recommending the retention of a qualified consultant for remediation.

Furthermore, several products, including “(b)(