Drugs

CGMP Violations at India’s USV Private Limited

A 6/1-6/10/16 FDA inspection at USV Private Limited, Daman, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/10 Warning Letter. Specific violations include:

failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records; and
failing to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards.

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the letter says. “We acknowledge that you are using a consultant to audit your operation and assist in meeting FDA requirements.” USV was told to provide: (1) a comprehensive retrospective investigation into the extent of the inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of its drugs; and (3) a management strategy including details of a global corrective action and preventive action plan.

FDA says it has found similar CGMP violations at other facilities in the company’s network and a 2/2014 Warning Letter was issued to a Mumbai facility. “These repeated problems at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” the letter says.

The firm was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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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