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USFDA completes audit for Dr Reddys Shreveport plant, no observations issued


USFDA completes audit for Dr Reddys Shreveport plant, no observations issued

“The audit of our formulations Shreveport plant, Louisiana, USA, by the United States Food and Drug Administration (USFDA) has been completed with zero observations,” Dr Reddys

Hyderabad: Drug major Dr Reddy’s Laboratories recently said that the US health regulator has completed the audit of its Shreveport facility in the US without any observations.

In a regulatory filing, Dr Reddy’s said, “The audit of our formulations Shreveport plant, Louisiana, USA, by the United States Food and Drug Administration (USFDA) has been completed with zero observations”.

Read Also: Dr Reddys recalls 2770 bags of Levetiracetam Sodium Chloride injection in US market

As per USFDA, observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.

Dr Reddy’s Lab was founded by Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited, of Hyderabad.

Dr Reddy’s manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products.

Read Also: Dr Reddy’s re-launches Buprenorphine, Naloxone Sublingual Film in US market



Source: With inputs
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