Drugs

CGMP Violations Found at Claris Injectables

A 7/27-8/4/17 FDA inspection at Baxter’s Claris Injectables, Ahmedabad, India, found significant violations of current good manufacturing practice (GCMP) regulations for finished pharmaceuticals. A 7/5 Warning Letter says specific violations were:

failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failing to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced; and
failing to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair.

The letter tells the company to submit (1) a comprehensive investigation into the extent of inaccuracies in data, records, and reporting, including results of the data review for drugs distributed to the U.S.; (2) a current risk assessment of the potential effects of the observed failures on drug quality; and (3) a management strategy that includes details of a global corrective and preventive action plan.

FDA strongly recommended that the company retain a qualified consultant to assist it in meeting CGMP requirements and to perform a comprehensive audit of the company’s entire operation for CGMP compliance and evaluate the completion and effectiveness of any corrective and preventive actions.

The letter notes that similar CGMP violations were reported in an 11/1/10 Warning Letter and said the “repeated serious violations at your facility demonstrate that your facility’s oversight and control over the manufacture of drugs is inadequate.”

Claris was told to respond with a list of specific 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