The US Food and Drug Administration has cited a drug manufacturing facility in Gujarat, India of Sun Pharmaceutical Industries, a Mumbai, India-based pharmaceutical company, with three observations.

The FDA conducted a GMP inspection of Sun Pharmaceutical’s Halol facility (Gujarat, India) from February 12-23, 2018. At the conclusion of the inspection, the agency issued a Form 483, with three observations.

An FDA Form 483 is issued to company management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related acts. 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, according to information from the FDA.

The company says it is preparing the response to the observations, which will be submitted to the FDA within 15 business days of the report issued to Sun on February 23, 2018.

The observations are the latest in manufacturing issues at the Halol plant. In May 2017, Sun Pharma Advanced Research Company Limited (SPARC), part of Sun Pharmaceutical Industries, received a Complete Response Letter (CRL) from the FDA regarding manufacturing issues at Sun Pharma’s Halol, India manufacturing site. The CRL related to a new drug application for Elepsia XR (levetiracetam extended-release tablets 1000 mg and 1500 mg), an anti-epileptic drug. In January 2016, the FDA issued a Warning Letter to Sun Pharmaceutical as a result of a September 2014 inspection at the Halol facility, which manufactures injectable products for the US market.

Source: Sun Pharmaceutical Industries (Bombay Stock Exchange)