Dr. Reddy’s Laboratories has received a Form 483 with seven observations from the United States Food and Drug Administration (USFDA) following an inspection at its formulations manufacturing facility in Srikakulam, Andhra Pradesh.

According to an exchange filing, the USFDA conducted a good manufacturing practice (GMP) and pre-approval inspection at the facility between July 10 and July 18. The company stated it will address the observations within the stipulated timeframe.

A Form 483 is issued at the end of an FDA inspection when investigators observe any conditions that, in their judgment, may violate the Food, Drug, and Cosmetic (FD&C) Act or related regulations.

These observations typically indicate practices that could result in a product being adulterated or rendered harmful if not addressed. However, the issuance of a Form 483 does not represent a final determination of non-compliance by the agency.

“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,” the regulator states on its website.

However, the issuance of a Form 483 does not represent a final determination of non-compliance by the agency.

Headquartered in Hyderabad, Dr. Reddy’s Laboratories is a global pharmaceutical company engaged in the development, manufacturing, and marketing of generic formulations, active pharmaceutical ingredients (APIs), and biologics.