The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / GMPs

Merck Flagged By FDA for Glass Deviation Inquiry

Dec. 27, 2013
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Merck KGaA’s Mexican subsidiary received a Form 483 for inadequately looking into a glass defect and not examining devices used in its products. During an August inspection of the company’s Naucalpan de Juarez, Mexico, facility, investigators found records that glass defects were observed in certain vials last year.
Drug GMP Report