Synovics subsidiary cited by FDA for poor quality control

By Elaine Rigoli

Tampa, Fla., Aug. 22 - The Food and Drug Administration notified Synovics Pharmaceuticals, Inc. that the findings of the periodic investigation of the company's recently acquired subsidiary, Kirk Pharmaceuticals, found a number of deficiencies in the quality-control procedures and other processes.

The FDA noted discrepancies in manufactured batches of pharmaceutical products, internal review and record failures, failures to follow production and quality-control guidelines, inadequate training of personnel, inadequate staffing and inadequate laboratory controls and product labeling.

Synovics is establishing corrective measures to ensure that the operations and procedures of Kirk address the deficiencies identified.

Synovics is a pharmaceutical company located in Phoenix.

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