FDA Sends Form 483s to Lupin, Aurobindo and Cipla Sites

Regulatory NewsRegulatory News | 14 October 2019 |  By 

Following inspections in late September, India-based generic drugmakers Lupin, Aurobindo and Cipla received Form 483s posted last week by the US Food and Drug Administration (FDA) for observations related to cleanliness, investigations into out-of-specification results and other deficiencies.

Lupin’s site in Tarapur, India was inspected over five days in late September, and the partially redacted 483 includes three observations. The first questions the company’s investigation into metal particle contamination, noting: “Your Quality team did not include all the batches manufactured during the campaign for a risk evaluation.”

FDA raised further questions about the site’s batch production and control records, as they do not include complete information relating to the production and control of each batch. The inspection also uncovered failures related to handling and storing “cleaned utensils in a manner to prevent contamination.”

For Aurobindo, the FDA inspection resulted in seven observations, following a seven-day inspection in late September at the manufacturer’s Polepally, India-based site.

“Specifically, your firm’s investigations were found to be deficient in that the Out of Specification (OOS) results have been invalidated for various tests without identifying scientifically sound and justifiable root causes,” the 483 says, noting several examples of such OOS investigations.

FDA also raised issues with Aurobindo’s product complaint investigations and deficiencies with its approach to commercial process validation. And Aurobindo also failed to provide FDA with all the requested documentation.

“Several lists of documents requested were either provided as incomplete, inaccurate, and or explained with potentially misleading statements throughout the inspection,” the 483 says, noting contradictory statements from two members of Aurobindo’s corporate quality group.

And the 11-day inspection at Cipla’s site in Goa, India, resulted in 12 observations. Cleaning-related issues make up a large portion of the 38-page Form 483.

Other deficiencies are related to aseptic processing areas, procedures designed to prevent microbiological contamination and specifications for in-process materials. Cipla also failed to “thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed” in some instances, the Form 483 says.

Form 483s


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