Drugs

CGMP Violations Found in Teligent Inspection

A 4/22-5/20 FDA inspection at Teligent Pharma, Buena, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/26 Warning Letter says the inspection also revealed that the firm failed to submit NDA field alert reports as required by law and regulations. Specific CGMP violations were listed as:

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 was already distributed;
failing to follow an adequate written testing program designed to assess the stability characteristics of drug products to use results of stability testing to determine appropriate storage conditions and expiration dates;
failing to follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product including the review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation; and
failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess.

The letter also lists violations of the field alert reporting requirements for three generic drug products that were not provided to FDA within three working days of date of discovery of out-of-specification results.

“We remain concerned with the continuing CGMP violations demonstrated at your facility and failure to report field alert report related events within three days of becoming aware of the problem,” the agency wrote. “Please include in your written response the corrective action you plan to take regarding distributed products manufactured at your facility that may be affected by the violations.” The letter also notes that similar CGMP observations followed a 10/2017 inspection and the company proposed specific remediation for those observations. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” it says.

Teligent was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion of the steps.

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