Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
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.”
The FDA said the violations observed during the inspection, include, but aren't limited to, the following:
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.
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:
“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.
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 email@example.com
To contact the editor responsible for this story: Dana A. Elfin at firstname.lastname@example.org
The warning letter is at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm495535.htm.
Notify me when updates are available (No standing order will be created).
Put me on standing order
Notify me when new releases are available (no standing order will be created)