FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Aurobindo Scolded Yet Again for Manufacturing Violations

April 22, 2019
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The FDA has cracked down once again on Indian pharma giant Aurobindo for manufacturing deficiencies at one of its facilities, slamming the company with yet another Form 483 over drugmaking violations and quality concerns.

The 11-observation Form 483—which stemmed from a Feb. 22-March 1, 2019 inspection of the drugmaker’s Mahabubnagar, Telangana facility—criticized the plant’s quality control unit, which failed to take properly assess CGMPs and their effect on finished sterile drug products, the agency said.

From Sept. 2017 to April 2018, the firm received 12 complaints about particles discovered in nine batches. For five of them, the firm declared there was no impact on product and explained away the particles as part of the manufacturing process. Analysis of two returned complaint samples found unidentified material, but the firm did not identify the causes.

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