New Delhi: The US Food and Drug Administration has issued an establishment inspection report to Dr Reddy’s Laboratories Ltd’s bulk drug manufacturing plant 2 at Bollaram near Hyderabad, indicating closure of the audit done in July, the company said in an exchange filing today.
The regulator has also classified the adverse observations made in a Form 483 as Voluntary Action Initiated, which indicates that the observations do not require immediate redressal.
However, the company does have to address the issues as the US FDA could classify similar observations that come up in future inspections as “official action indicated", which makes it mandatory for companies to undertake remedial measures immediately.
The US FDA had inspected the active pharmaceutical manufacturing (API) manufacturing plant in July, after which it had issued five observations. One of the observations was that the company did not actively investigate complaints by customers on test results which were out of specifications from what was in place for the product. A copy of the Form 483 was reviewed by Mint.
Active pharmaceutical ingredients, or bulk drugs, are key raw materials for drug formulations.
The regulator in its Form 483 also pointed out that the company did not have preventive controls for its electronic inventory and warehousing management systems were not effectively established.
The active ingredients and custom pharmaceutical services segment contributed around 15% to the Hyderabad-based drug maker’s consolidated net revenue of Rs. 38.4 billion in the June quarter. Most pharmaceutical companies do not disclose the revenue break-up from their various plants.