FDA WARNING_LETTER - Advanced Testing Laboratory Inc - April 09, 2010

During a February-April 2010 inspection, FDA identified significant Current Good Manufacturing Practice (CGMP) violations at Advanced Testing Laboratory, Inc., a pharmaceutical contract testing laboratory. These violations render clients' drug products adulterated. The firm's April 29, 2010, response was deemed insufficient.

Key violations include: 1. **Unsound Test Procedures (21 CFR §211.160(b))**: Desiccated Agar plates were used for microbial testing, and the firm lacked criteria for personnel contamination in colony counts, potentially leading to inaccurate results. 2. **Inadequate Instrument Calibration (21 CFR §211.160(b)(4))**: Several instruments were out of calibration or lacked proper maintenance records. Incubators were not properly qualified with heat distribution studies. 3. **Unvalidated Test Methods (21 CFR §211.165(e))**: The firm performed analytical method transfers for 236 protocols without confirming client method validation. 4. **Quality Control Unit Deficiencies (21 CFR §211.22(d))**: The QCU failed to fully document and evaluate 946 internal defects, lacking required reports and trend analysis. 5. **Failure to Follow Procedures (21 CFR §211.160(a))**: Expired USP standards were present, formula