FDA letter takes issue with Micro Labs' data practices

Count another Indian API producer on the FDA's regulatory radar. Four months after issuing an import ban on products made at a Micro Labs plant in Bangalore, the agency outlined the violations.

In a four-point warning letter last month, the FDA officials described "significant violations" of CGMP regulations inspectors found during a May 2014 visit. The FDA barred the plant's products from entering the U.S. in September.

According to the FDA, Micro Labs personnel failed to ensure that laboratory records included complete data; exercise appropriate controls over computer systems; record and justify any deviations from required laboratory control mechanisms; and submit NDA/ANDA reports within three working days within receipt of vital information concerning distributed drug products.

"The above examples are of serious CGMP deficiencies and violations demonstrating that your quality system does not adequately ensure the accuracy and integrity of the data generated and available at your facility to support the safety, effectiveness, and quality of the drug products you manufacture," the letter stated.

As a result, the FDA may withhold approval of any new applications or supplements listing Micro Labs as a supplier. The FDA recommended that the company hire a third-party auditor and ordered a response within 15 working days including a comprehensive investigation and management strategy. Further regulatory action is possible if Micro Labs fails to address the issues.

Micro Labs joins a host of Indian pharma manufacturers where the FDA has found serious manufacturing shortcomings. Most recently, the agency issued a scathing warning letter against an Apotex plant in Bangalore. The FDA has previously taken issue with production practices in plants operated by Ranbaxy Laboratories, Ipca Laboratories, Wockhardt and Sun Pharmaceutical.

- here's the warning letter
- and the import alert

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