FDA WARNING_LETTER - Canton Laboratories Pvt. Ltd. - April 09, 2013

On February 27, 2014, the FDA issued a Warning Letter to Canton Laboratories Private Limited in Vadodara, India, following an inspection from April 1 to April 9, 2013. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs), rendering their APIs adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Failure to perform laboratory testing and accurately report results:** The firm reported microbial limits and metallic impurities on Certificates of Analysis (CoAs) without performing the tests or having raw data. This was a repeat violation from a 2008 inspection. 2. **Failure to maintain complete laboratory data:** Raw data from the Atomic Absorption Spectrophotometer (AAS) was deleted, with only 38 files found despite over 400 analyses, raising concerns about data integrity. 3. **Inadequate equipment cleaning and validation:** Product residue was found on "clean" non-dedicated equipment, and cleaning validation studies lacked recovery studies, indicating potential cross-contamination. 4. **Failure to follow pre-approved instructions and maintain complete batch records:** Incorrect amounts of starting materials were used due to erroneous calculations, batch production records lacked operator signatures, and contained missing information (e.g., "nil" pH readings). This was