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Ipca Laboratories Faces U.S. FDA Scrutiny Over Three Lapses At Silvassa Facility — BQ Exclusive

U.S. FDA inspected the Silvassa facility from April 18 to April 26 and issued Form 483 with three observations.

<div class="paragraphs"><p>Source: Unsplash</p></div>
Source: Unsplash

The U.S. drug regulator has flagged three quality and procedural lapses at Ipca Laboratories Ltd.’s formulations manufacturing unit located at Piparia in Silvassa.

"The U.S. FDA conducted the inspection of the company's formulations manufacturing unit situated at Piparia (Silvassa) from April 18 to April 26," the company had said in an April 27 exchange filing. "At the conclusion of the inspection, the U.S.FDA issued a Form 483 with three observations."

A Form 483 is issued when investigators have observed any condition that, in their judgement, may constitute a violation of the Food, Drug, and Cosmetic Act and related acts.

"The company will submit its comprehensive response on these observations to the U.S. FDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest," the company had said in the filing.

BQ Prime has obtained a copy of the three observations from the U.S. FDA.

These are:

  1. Failure to review any unexplained discrepancy and failure of a batch or its components to meet specifications, whether or not the batch is distributed. U.S. FDA identified two out-of-specification results that were invalidated without a scientifically justified root cause. It also noted two out-of-trend issues at the facility.

  2. Responsibilities and procedures applicable to the quality control unit are not in writing and are not fully followed. Four instances of the firm's failure to ensure deviation investigations and associated corrective and preventive actions are timely and documented were identified. Also, the training provided to analysts for performing test procedures was not effective.

  3. Quality assurance and quality control units lacked adequate responsibilities and authorities to assure reliable operations. There was a failure to initiate or close corrective and preventive actions for the data integrity issues observed during the inspection and assess the risk to patients and potential effects of the data integrity failures on the quality of the drug products affected by the lapse of data integrity. Three such instances were identified.

Ipca Laboratories has yet to respond to BQ Prime’s emailed queries on the implications of the observations, revenue from the facility, and impact. Also, any pending approvals and launch timelines. It’s also yet to comment on the steps being taken to address these issues and the expected timelines for resolution.

Shares of Ipca Laboratories were trading 0.17% lower, compared with a 0.44% rise in the Sensex, as of 10:41 a.m.