BRIEF—FDA sends five warning letters for manufacturing violations
19 January 2018
The US Food and Drug Administration has sent a warning letter to five drugmakers for violations of current good manufacturing practice (cGMP).
RAPS reports that the violations related to finished pharmaceuticals and active pharmaceutical ingredients (APIs).
The companies are:
- Schrofner Cosmetics, Austria — The FDA said the firm lacked an adequate quality control site and failed to prepare any master production records or batch production records.
- Delta Laboratories, Australia — The FDA found Delta did not have adequate process validation studies, and failed to thoroughly investigate testing failures related to two batches of a drug product.
- Shanwei Honghui Daily Appliance, China — FDA inspectors noted machines were “filthy and were surrounded by cardboard and dirty rags,” and warned there were no test records to support the release of drug products.
- Yicheng Chemical, China — The API manufacturer was said to have failed to use separate facilities to manufacture two products. In addition the firm did not have repackaging batch records.
- Wuhan Chinese Moxibustion Technology, China — The agency cited inadequate record-keeping.
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