Sun Pharma Dinged by FDA for cGMP Violations

The FDA is asking Sun Pharmaceuticals to conduct tests and turn over reams of paperwork in response to a warning letter alleging more than a dozen cGMP violations.

The alleged violations, which the company disclosed prior to the FDA posting the letter on its website Dec. 29, address everything from untested ventilation systems and unhygienic practices to the use of uncalibrated equipment.

To address these and other issues, the agency asks the company to perform the following tasks:

• Send the FDA a video of dynamic smoke studies testing the airflow in the facility along with a description of associated upgrades planned;
• Provide a risk assessment on recording vial rejections and a set of standard operating procedures for dealing with such issues;
• Create a summary of the company’s environmental data since September 2014, along with six months of data on environmental controls and microbial testing;
• Write a progress report on efforts to identify unexplained production peaks;
• Detail the results of a formal investigation, including quantitative results obtained and copies of all raw data;
• Provide a summary of the company’s quality system testing methodology; and
• Detail revised testing procedures and a validation report.

While warning letters typically ask recipients to respond with proof that they have fixed reported problems, they typically do not delve into that level of specificity.

The FDA’s claims stem from a September 2014 inspection during which agency officials encountered a laundry list of supposed violations: rejection of vials without explanation, failure to perform unannounced sterility testing, the use of buckets to catch water falling from holes in the ceiling, failure to conduct smoke studies, the absence of testing for batch failures, unaddressed sterility reports, failure to verify the validity of testing methods, the use of partially unsterilized gloves, the use of uncalibrated equipment, minimal efforts at ensuring data security and inadequate record keeping.

Sun Pharma says in a release that it is working to correct the alleged violations and will provide the agency with “a detailed plan” within the time frame specified by the agency.

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