FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Indian Manufacturer Cited for Cleaning Deficiencies, Poor Complaint Handling

Sept. 28, 2018

Symed Labs was hit with a Form 483 after an FDA inspection of its Hyderabad, Telangana facility revealed equipment cleaning and complaint handling violations.

During the May 7 to 11 inspection, FDA investigators found that the firm took swab samples from pre-determined locations to evaluate the effectiveness of its equipment cleaning, but failed to sample the most difficult areas to clean.

Additionally, the agency flagged shortcomings in the way the firm handled complaints. In one complaint, a customer rejected three lots of APIs after they failed the solution color test. Despite this, the firm concluded that there were no errors after it finished its complaint investigation, and resold the API lots to other customers for use in tablets after they were returned.

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