The QMN Weekly Bulletin
Pharmaceuticals / Quality / GMPs / Inspections and Audits

Indian API Maker Warned for Recordkeeping, Batch Testing Violations

March 14, 2014

The FDA has warned an Indian active pharmaceutical ingredient (API) manufacturer for a laundry list of severe quality violations, such as failing to test batches and losing records.

The warning letter to Canton Laboratories, published March 11, stems from an April 2013 inspection of its API plant. The agency said many of the violations it found were repeat offenses.

One such violation centered on releasing three API batches without data to show they met specifications. The manufacturer reported microbial limits results on certificates of analysis (CoA) for the three batches, but didn’t actually perform the tests, the letter reads.

“Similarly, our inspection found other examples where your firm did not have raw data, yet reported testing as acceptable on your CoAs,” the FDA said.

Canton’s response was to revise standard operating procedures and perform training on those new procedures. However, that response was nearly identical to one promised regarding a similar violation uncovered during a July 2008 inspection, the letter states.

“It is concerning that your commitments in the previous response did not address the underlying issues,” the agency said.

The FDA was also alarmed by missing raw data generated by the company’s Atomic Absorption Spectrophotometer (AAS), used for elemental analysis testing. The instrument doesn’t have adequate controls to prevent unauthorized users from deleting or changing data files, investigators found.

“Our inspection uncovered only 38 raw data files on the hard drive of the AAS, while analysts stated that the AAS has been used for over 400 analyses,” the agency said. “Your firm failed to store the raw data elsewhere. Therefore, all AAS testing results for which no raw data exists are in doubt.”

The FDA also cited Canton for failing to properly investigate complaints, perform stability studies, investigate out-of-specification results and clean equipment after use. 

The agency says in addition to hiring a third-party good manufacturing practices consultant and creating an action plan to address the observations, it wants a detailed investigation into the extent of the record destruction and the missing test results. The investigation should detail how these violations impacted product quality, and how the company will prevent “fundamental breaches of data integrity and management oversight in the future,” the FDA said.

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