FDA Warns Indian Drug Firm of Data Integrity Violations

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April 20 — In a warning letter posted to the FDA's website April 19, the agency warned Sri Krishna Pharmaceuticals Ltd. about several current good manufacturing practice (cGMP) violations involving data integrity issues found at its facility in Hyderabad, India.

The Food and Drug Administration told the company that the violations mean the drug products produced at the facility are adulterated. The FDA said it observed similar violations at the facility in 2007.

The agency said the violations were discovered during an FDA inspection that ended Dec. 4, 2014. The FDA said the company's response, dated Dec. 24, 2014, but the response “lacks sufficient corrective actions.”

Specific Violations

The FDA said the violations observed during the inspection, include, but aren't limited to, the following:

  •  failure to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards;
  •  failure to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records;
  •  failure to follow written procedures for product and process control designed to assure that drug products have the correct identity, strength, quality and purity, and to document same at the time of performance; and
  •  failure to establish adequate written procedures for production and process control designed to assure that drug products have the correct identity, strength, quality and purity.


The FDA said that Sri Krishna is a contract manufacturer for several drug products and its failure to comply with cGMP may affect the quality, safety and efficacy of the drug products it manufactures for its clients.

“It is important that you notify your customers of significant problems or discrepancies you encounter during the testing and/or manufacturing of their products,” the agency said.

Corrective Actions

The FDA said it acknowledges that Sri Krishna is using a consultant to audit its operations and assist in meeting the FDA's requirements.

“However, it is your responsibility to ensure that any third-party audit appropriately evaluates the vulnerability of your sophisticated electronic systems to data manipulation,” the warning letter said. “It is also your responsibility to ensure that follow-up actions fully resolve all of your violations.

The agency asked the company to respond to the warning letter and provide:

  •  an assessment of the extent of the inaccuracies in data records and reporting,
  •  a current risk assessment of the potential effects of the observed failures on the quality of drugs, and
  •  a management strategy that includes the details of a global corrective action plan.


“Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm's compliance with cGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer,” the letter said.

In addition, the letter said the firm's failure to correct these violations could result in the FDA “continuing to refuse admission of articles” into the U.S.

Francis Godwin, acting director of the Office of Manufacturing Quality, Office of Compliance, FDA's Center for Drug Evaluation and Research, signed the letter.

Draft Guidance

Meanwhile, due to an increase in cGMP violations involving data integrity, which has led to warning letters, import alerts and consent decrees, the agency recently released a draft guidance for industry to clarify the role of data integrity in cGMPs for drugs. A notice announcing the draft guidance was published in the April 15 Federal Register (81 Fed. Reg. 22,281).

“When finalized, the draft guidance is intended to provide the agency's current thinking on the creation and handling of data in accordance with cGMP requirements,” the agency said. The guidance's title is “Data Integrity and Compliance With CGMP.”

Comments on the draft guidance are due June 14.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Dana A. Elfin at delfin@bna.com

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