Regulatory Focus™ > News Articles > 3 > FDA Form 483 for Dr. Reddy’s: Quality Unit Failed to Close CAPAs

FDA Form 483 for Dr. Reddy’s: Quality Unit Failed to Close CAPAs

Posted 27 March 2018 | By Zachary Brennan 

FDA Form 483 for Dr. Reddy’s: Quality Unit Failed to Close CAPAs

Following an inspection earlier this month at Dr. Reddy’s Laboratories’ Medak, India-based site, the US Food and Drug Administration (FDA) sent the firm a Form 483 with five observations, including the site’s failure to close multiple corrective and preventive actions (CAPAs).

FDA said the CAPAs were not closed within the allowable timeframe, and a justification to extend the completion timeframe was not requested for CAPAs initiated in 2016 and 2017.

Dr. Reddy’s was also cited for not establishing quality agreements with some starting materials suppliers and FDA also said the firm’s quality unit failed to close complaint investigations within the allowable timeframe.

“Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of API [active pharmaceutical ingredient] finished materials prior to release,” FDA added in the fourth observation. Dr. Reddy’s disclosed the Form 483 on 16 March in a filing.

Form 483 for Cipla

Meanwhile, on Tuesday, FDA released a Form 483 sent to Goa, India-based Cipla’s manufacturing site following an inspection in January.

The Form 483 included seven observations, highlighting deficiencies in the firm’s quality control unit, in addition to issues with certain batches of product.

“For each batch you generate a CoA [Certificate of Analysis] for microbial test results for the finished product, a CoA for different stages in the manufacturing process, and a CoA containing both chemical and microbial test results for the finished product. You use the same format for all CoAs,” FDA said. “There is no clearly identifiable distinction to identify the one authentic CoA for the finished product.”

Dr. Reddy’s Form 483

Cipla Form 483
 

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