FDA Finds Quality Documents Stuck in a Shredder at Glenmark Facility

Posted 05 December 2017 By Zachary Brennan


The US Food and Drug Administration (FDA) on Tuesday released a heavily redacted Form 483 sent last month to Glenmark Pharmaceuticals' Solan, India-based manufacturing facility.

One of the seven observations in the Form 483, first announced by the company on 28 November, noted that FDA inspectors found at least 13 quality documents "shredded in the teeth and surrounding internal moving parts of the shredder."

FDA said the quality documents were not listed on the logbook for shredding as required by one of the site's standard operating procedures.

Other observations dealt with the site's failure to thoroughly review unexplained discrepancies and batch failures, deficiencies related to complaint records and a lack of written procedures for production and process controls.

In one instance, the Form 483 says the company attributed a batch failure to sample preparation error "by providing photographs of sample vials indicating the purported anomalous sample preparations. The photographs included in the investigation did not include a date stamp … Authenticity of the supporting photographs could not be verified by the FDA investigators."

Glenmark said the manufacturing unit that received the Form 483 contributes to about 10% of the company's US sales and that the company "is in the midst of providing a comprehensive response to the observations."

Form 483

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Categories: Drugs, Crisis management, Ethics, Regulatory strategy, News, US, FDA

Tags: Glenmark Pharmaceuticals, Form 483

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