During their last investigation in April 2013 at Canton Laboratories- Vadodara, U.S. food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) and in view of it, FDA issued a warning letter.
As per their inspection FDA observed that Canton laboratories was failed to perform laboratory testing of APIs to ensure conformance to specifications and to accurately report results on Certificates of Analysis and also failed to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.
Additionally FDA was found several other observations of particular concern, such as your firm’s: failure to properly investigate customer complaints, failure to properly investigate out-of-specification results, failure to follow your Master Validation Plan for process validations or equipment calibrations, failure to provide adequate resources to the quality unit, failure of your quality unit to properly review production records and detect instances where testing was not performed to support company’s certifications on COAs, failure to perform appropriate stability studies for product currently in the market, failure to establish an impurity profile for product currently in the market.
FDA asked Canton Laboratories to notify back within fifteen working days about specific steps taken to correct and prevent the recurrence of deviations, and provide copies of supporting documentation.
