Friday, June 1, 2012

5/29/12 - Warning Letter Analysis: Device Companies, Tissue Bank Hit Hard for Deficiencies

Learn more details about these companies, and why they received warning letters.

Warning Letter Analysis: Device Companies, Tissue Bank Hit Hard for Deficiencies - RAPS - News - Article View:

"The US Food and Drug Administration’s (FDA) newest batch of warning letters was released on 29 May 2012, and some familiar faces have come under further scrutiny.

Medical device manufacturer McNeil PPC, a subsidiary of Johnson & Johnson, was hit with a lengthy list of claims by FDA, which said the firm is manufacturing no fewer than ten adulterated products. Three of the company’s Pennsylvania facilities are currently the subject of an FDA consent decree after the facilities repeatedly experienced manufacturing deficiencies and “several extensive recalls.” The company’s recent warning letter is extensive enough to draw parallels to the deficiencies which lead to the consent decree.

Medical device manufacturers Advanced OrthoPro Incorporated and Lebanon Corporation Incorporated also received citations for Quality System Regulation (QSR) deficiencies, while tissue bank company Gramercy Fertility Services was found to have violated human cells, tissues and cellular and tissue-based product (HCT/P) regulations."

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