Regulatory Focus™ > News Articles > 2019 > 3 > FDA Warns Teva Subsidiary Over Quality Failures, CGMP Violations

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Posted 06 March 2019 | By Zachary Brennan 

FDA Warns Teva Subsidiary Over Quality Failures, CGMP Violations

Teva Pharmaceuticals subsidiary Actavis Laboratories FL, Inc. received a warning letter last month from the US Food and Drug Administration (FDA) for quality unit concerns and inconsistencies with its laser-drilled tablet manufacturing processes, among other violations.

Actavis Laboratories’ quality unit at the Davie, Florida-based site was found to have “failed to fulfill its duties and responsibilities,” the warning letter says, noting for example that the unit did not ensure robust oversight of its laser drilling process.

“Since 2015 your firm was aware of various process performance (e.g., no or misplaced hole in tablets) and drug product quality data (e.g., recall due to dissolution failure) that indicated a lack of control of your laser drilled drug products. However, your firm failed to ensure timely investigations and corrective and preventative actions (CAPA),” the warning letter says. FDA inspected the site over 10 days last July.

Product failures related to the manufacture of paliperidone extended release tablets were also cited in the warning letter.

“Two investigations identified two different possible root causes for undrilled tablets in the same batch of drug product. Neither sufficiently addressed the fundamental failure to adequately drill a hole in the tablet,” the letter adds.

FDA also notes how the site has been cited for similar CGMP violations in three previous inspections in December 2013, January 2016 and November 2017. “These repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA said.

In addition, the site failed to adequately qualify operators who perform in-process checks and failed to perform acceptable quality level inspections of its laser-drilled drug products.

Actavis Laboratories FL, Inc. 2/1/19


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