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Hetero Labs gets USFDA Warning Letter

Hyderabad based Hetero labs received a warning letter from US FDA for serious violation of current Good Manufacturing Practices (cGMP) following an inspection at its Jadcherla facility in Telangana.

USFDA inspection occurred between December 07 2016 to December 16 2016 which lead to the observations by inspection team. There were three major violations of cGMP cited by USFDA team in its warning letter addressed to Hetero Labs Chairman and managing director, BandiParthasarathy Reddy.

The observations by USFDA are as follows:

Adding further to its observations, USFDA team said the Hetero labs were solely responsible for producing sub-standard quality of drugs at the Jadcherla facility. It warned Hetero that because its methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, its drug products were adulterated as per US law.

The USFDA warned Hetero Labs to strictly comply with cGMP failing to which may result in FDA refusing admission of articles manufactured at the company's Unit V at JadcherlaMandal into the US.

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