FDA Inspection Finds Data Manipulation, Other cGMP Violations at Apotex’s India Plant

Canadian generics maker Apotex’s plant in Bangalore, India, has rampant problems with data manipulation, including continuously retesting batches until the desired result is achieved, the FDA charged in a warning letter.

Inspectors visiting the plant from Jan. 27 through Jan. 31 found serious current good manufacturing procedure (cGMP) deviations, the FDA wrote, noting that initial replies from Apotex have not been sufficient to allay the agency’s concerns.

“Our inspection revealed that your firm selectively omitted cGMP records directly related to the testing and manufacturing of your products,” according to the letter. The lack of accurate documentation has been cited before, in inspections at the facility in 2006 and 2010, the agency said.

Among the violations cited in the new letter:

• Not all raw product testing data was stored at the facility, despite the cGMP mandate to do so.
• Unfavorable test results were discarded.
• Documented peaks in high performance liquid chromatography testing of active pharmaceutical ingredient compounds were not investigated.
• Complaint investigations were not adequately documented.
• Testing times did not match when the records said they occurred.

In the product testing process, “the common practice was to complete the analysis and to record the sample preparation data only if the results were acceptable. If the results obtained were atypical, a fresh sample was to be prepared and analyzed. The original sample testing was not recorded,” the warning letter charges. 

“The above examples raise serious concerns regarding the integrity, reliability and accuracy of the data generated and available at your facility,” the FDA said.

In early May the FDA placed the India plant’s products on an import ban list, citing a need for quality upgrades. The current letter warns that until the plant’s manufacturing problems are resolved, its products will continue to be subjected to that ban and future ANDAs could also be at risk.

The company faced similar bans on two of its Ontario facilities in 2012.

The warning letter requests that Apotex provide the agency with a comprehensive evaluation of the extent of the omission, deletion and destruction of records, a risk assessment regarding the potential impact on the quality of products, and a comprehensive corrective and preventive action plan.

Apotex did not respond to a request for comment by press time.

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