Deb USA Inc. – FDA Warning Letter, Oct 30, 2018

The FDA issued a Warning Letter to SC Johnson Professional, Inc. (formerly Deb USA, Inc.) following an inspection from October 22-30, 2018, citing significant violations of CGMP regulations for finished pharmaceuticals and drug product registration/listing requirements.

Key CGMP violations include: 1. **Failure of the Quality Control Unit (QCU):** The QCU failed to follow procedures, releasing drug products (antimicrobial hand soaps, sanitizers) before reviewing microbiology test results and delaying investigations into out-of-specification (OOS) results. 2. **Inadequate Laboratory Controls:** The firm lacked a procedure for HPLC data integration and used inconsistent replicate injections, leading to unscientific data manipulation and reporting of passing results without justification. 3. **Failure to Follow Laboratory Procedures:** Laboratory personnel did not adhere to procedures for viable microorganism enumeration (e.g., plate preparation, sample testing volume), and microbiological testing activities were not contemporaneously documented, with discarded test plates found. Desiccated agar plates were also in use. 4. **Incomplete Laboratory Records and Data Integrity Issues:** Instances of overwriting electronic data, discarding original records, and failing to report OOS results were found. HPLC software allowed data manipulation, and OOS results were not reported. 5. **Release Without Appropriate Microbiological Testing:** Drug products were routinely released before complete microbiological testing, as evidenced by a recalled lot due to potential contamination