Toxin Technology, Inc. – FDA Warning Letter, Aug 10, 2010

An FDA inspection of Toxin Technology, Inc., an API contract testing laboratory in Sarasota, Florida, from August 9-10, 2010, revealed significant Current Good Manufacturing Practice (CGMP) deviations, causing client APIs to be adulterated. The firm's September and October 2010 responses to the FDA 483 were not considered due to late submission.

Key violations include: 1. **Quality Unit Failures:** The Quality Unit failed to ensure appropriate material testing and accurate reporting, with numerous instances of passing results reported after failing results were obtained (e.g., SPL #10-572, #10-573, #10-1326). Inaccurate results were also reported to clients for Pancrelipase samples. 2. **Method Validation:** Analytical methods, specifically for Bacillus Diarrheal Enterotoxin (BDE), were not appropriately validated, lacking developed protocols and complete validation studies. 3. **OOS Investigations:** The firm lacked a procedure for investigating and documenting Out-of-Specification (OOS) test results and failed to investigate numerous OOS results. 4. **Equipment Qualification:** Analytical equipment used for BDE testing, specifically plate readers, had not been calibrated on a quarterly basis since 2007, as required by their operation manual. 5. **Record Keeping:** Raw data records for approximately 150 Pancrelipase