FDA issues warning letter to Hetero Labs on Telangana facility
New Delhi: The US health regulator has issued a warning letter to Hyderabad-based Hetero Labs for significant violations of good manufacturing norms at its facility in Jadcherla in Telangana. The issues that were raised included failure to clean, maintain, sanitise and sterilise equipment and utensils at appropriate intervals used for manufacturing of drugs at the facility, the United States Food and Drug Administration (USFDA) said. USFDA investigators had inspected the company’s drug manufacturing facility on 7-16 December, 2016.
The letter also pointed out that the company does not have an adequate ongoing programme for monitoring process control to ensure stable manufacturing operations and consistent drug quality at Unit V facility at Jadcherla.
Besides, the USFDA letter, which was addressed to Hetero Lab’s Chairman and MD Bandi Parthasarathy Reddy, said the firm failed to “establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures”.
The regulator asked the company for an overall assessment of the adequacy of the cleaning programme for all equipment, with special emphasis on difficult-to-clean parts. It also asked the company to provide detailed retrospective review of all complaints, manufacturing, and laboratory investigations associated with each product it produces for the US market and all lots that were within expiry.
The USFDA asked Hetero to engage a qualified consultant to help meet CGMP (Current Good Manufacturing Practice) requirements and warned that it could withhold any new approvals from the company till all the violations are corrected.
Failure to correct the violations may also result in the FDA refusing admission of articles manufactured at the company’s Unit V at Jadcherla Mandal in the US, it warned.
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