US FDA slams Indian lab for lack of raw data

The violations - detailed in a warning letter​ released in February - include the company’s failure to perform laboratory testing of APIs to ensure conformance to specifications and to accurately report results on Certificates of Analysis (CoA).  

The lab “reported microbial limits results on CoAs for three API batches without performing these tests…Your quality unit approved the release of these API batches without data to support that release specifications were met​,” the FDA said.

The inspection also found “other examples where your firm did not have raw data, yet reported testing as acceptable on your CoAs​.”  The company’s response to the 2008 observation, similar to its response to the current findings, was to correct the issue through retraining and document revision. “It is very concerning that your firm has not taken the proper actions to address the underlying issues​,” the FDA said.

Furthermore, the company also failed to prevent raw data from being deleted from the Atomic Absorption Spectrophotometer (AAS) used for elemental analysis testing. 

The FDA’s investigation found laboratory analysts had access to delete and overwrite AAS raw data, which “is especially concerning because our inspection uncovered only 38 raw data files on the hard drive of the AAS, while analysts stated that the AAS had been used for over 400 analyses​.” 

“Your firm failed to store the raw data elsewhere. Therefore, all AAS testing results for which no raw data exists are in doubt. Your firm’s improper control over the laboratory records raises concerns about the quality of the APIs your firm has released​,” the FDA said.

The company also failed to ensure its equipment is cleaned in a reproducible and effective manner to prevent contamination of a material that would alter the quality of its APIs.​

The FDA added that Canton had not made sure its APIs are produced according to pre-approved instructions and that batch production records include complete information pertaining to the production of each batch.

Additionally, the FDA noted other observations of particular concern, such as the company’s:

-       Failure to properly investigate customer complaints;

-       Failure to properly investigate out-of-specification results;

-       Failure to follow its Master Validation Plan for process validations or equipment calibrations;

-       Failure to provide adequate resources to the quality unit;

-       Failure of the quality unit to properly review production records and detect instances where testing was not performed to support your company’s certifications on your COAs;

-       Failure to perform appropriate stability studies for product currently in the market; and

-       Failure to establish an impurity profile for product currently in the market.