The US Food and Drug Administration (FDA) has cited a formulations manufacturing plant in Bachupally, Hyderabad, India of Dr. Reddy’s Laboratories, a Hyderabad, India-headquartered pharmaceutical company, with the issuance of a Form 483 with 11 observations following an inspection of the facility earlier this month (February 2019).

The Bachupally, Hyderabad, India plant had previously been cited by the FDA. The company received a Form 483 with 11 observations in 2017 following an FDA inspection completed in April 28, 2017. Dr. Reddy’s noted at that time that the observations were mostly procedural in nature and were related to the need to improve staff capabilities and strengthen documentation and laboratory systems.

The plant was also cited by European regulatory authorities. In January 2018, the company passed a GMP re-inspection carried out by German regulators at its formulations manufacturing plant (Unit 2) in Bachupally, Hyderabad. The re-inspection followed a failed inspection earlier in 2017. In August 2017, German pharmaceutical regulators issued a statement of noncompliance of GMP to Dr. Reddy’s for the dosage-form manufacturing plant (Unit 2).

In response to the observations in the newly issued Form 483 by the FDA, the company said, “We will address them comprehensively within the stipulated timeline,” according to February 9, 2019 company filing with the Bombay Stock Exchange.

In a separate development, Dr. Reddy’s said it is continuing a voluntary US recall, which began in October 2018, for one lot of levetiracetram, an antiepileptic drug, due to product mislabeling. The recall applies to levetiracetram in 0.54% sodium chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in the US.

The recall was originally initiated due to a product complaint received for mislabeling. The pre-printed text content on the infusion bag (primary container) for the lot indicates product information as levetiracetam in 0.75% sodium chloride injection (1000 mg/100 mL). The label on the external foil pouch has the product information as levetiracetam in 0.54% sodium chloride injection (1500 mg/100 mL). To date (as of February 4, 2019), the company says there have been no reports of adverse events related to this recall.

The batch was distributed in the US between August 14, 2018 and September 5, 2018.

Source: Bombay Stock Exchange and FDA