New Delhi : The US health regulator has red-flagged Mumbai-based drug firm USV Pvt Ltd for violations of manufacturing norms, including data integrity issues, at its Daman facility.
In a warning letter, the US Food and Drug Administration (USFDA) said the firm failed to establish laboratory controls designed to make sure components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity at its plant. The firm also “failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that includes validation of all aseptic and sterilisation processes”, the USFDA said.
The regulator stated that it had reviewed the company’s July 1, 2016, response in detail and also acknowledged receipt of subsequent correspondence, but the response was inadequate.
Acknowledging that firm was using a consultant to audit operation and assist in meeting FDA requirement, the regulator said: “Your quality system does not adequately ensure the accuracy and integrity of data to support safety, effectiveness, and quality of the drugs you manufacture.”
The warning letter to Managing Director Prashant K Tewari raised similar current good manufacturing practice (CGMP) violations at its other facilities.
“These repeated problems at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” the FDA noted.
The regulator said it had reviewed the company’s July 1, 2016, response in detail and also acknowledged receipt of subsequent correspondence.
“Until the company corrects all violations completely and we confirm your compliance with CGMP, the FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” it added.
Failure to correct these violations may also result in the FDA refusing admission of articles manufactured at the Daman facility, the USFDA said.