Drugs

FDA Warns Unexo Lifesciences Over CGMP

A 5/1-5/14 FDA inspection at the Unexo Lifesciences drug manufacturing facility in New Delhi, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/6 Warning Letter says specific violations were:

failure of the firm’s quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity; and
failure to clean, maintain, and, as appropriate for the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

The letter says that significant findings in the letter demonstrate that Unexo does not operate an effective quality system following CGMP. “In addition to the lack of effective management oversight of your production and laboratory operations,” it says, “we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.” The letter also says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs the firm manufactures.

Unexo’s responses to the inspection observations were inadequate, FDA says. The agency also documents a lack of access to information during the inspection and acknowledges the company’s decision to stop making products at the facility intended for the U.S. market. FDA asks to be notified in advance if the company intends to resume production for the U.S. market.

Unexo was told to correct violations promptly and to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome