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FDA to Revise Component GMPs to Bolster Supply Chain Security

The FDA is revising GMP regulations for incoming raw materials that would significantly improve drugmakers’ control over suppliers and help secure the pharmaceutical supply chain against economically motivated adulteration.

Published Fri, May 21 2010 19:28 by FoodSafetyNews

Tags: FDAnews – News
Lack of Written Procedures Leads to Warning to Florida Company

Clearwater Products has received an FDA warning letter related to a lack of written procedures for its devices. The Port Richey, Fla., company, which manufactures the Water Lily colonic irrigation system, does not have written internal audit procedures...

Published Thu, May 13 2010 23:19 by FoodSafetyNews

Tags: FDAnews – News
Paper Trails Are Best Protection Against Show-Shadow Factories

Manufacturers can avoid inadvertently doing business with show-and-shadow factories by scrutinizing foreign suppliers’ paperwork and specific details of their operations. When contracting with a foreign supplier, devicemakers should audit the supplier...

Published Mon, May 10 2010 22:44 by FoodSafetyNews

Tags: FDAnews – News
Proposed Rule Less Restrictive for Constituent Materials

Biologics manufacturers could gain some leeway on constituent materials under a rule the FDA has proposed in response to technological advances in development and manufacturing.

Published Fri, Apr 16 2010 17:54 by FoodSafetyNews

Tags: FDAnews – News
Sterilization and Audit Issues Cited in Guidewire Warning

Guidewire Technologies received a warning letter for not following sterilization procedures, adequately validating processes and conducting quality audits. The Salem, N.H., company, which makes guidewires used in catheters, did not test the product after...

Published Fri, Apr 9 2010 23:17 by FoodSafetyNews

Tags: FDAnews – News
Drugmakers May See Rise in Suits by FDA on Corporate Compliance

The FDA said it would increase prosecutions against corporate officials as part of its drive to improve its Office of Criminal Investigations, the same day a federal report criticizing the agency and its supervision of the office was released by the Government...

Published Fri, Apr 9 2010 18:51 by FoodSafetyNews

Tags: FDAnews – News
Proposed Rule on UDI Database Expected Soon, CDRH Says

CDRH expects to release a proposed rule for a unique device identifier (UDI) database this summer and is aiming at having a final rule in place by April 2011. Once the final rule is out, manufacturers of Class III devices will have one year to comply...

Published Fri, Apr 9 2010 0:11 by FoodSafetyNews

Tags: FDAnews – News
Biological Controls Is Warned for QS, Documentation Issues

Biological Controls has been warned for several quality system (QS) and documentation failures, including failure to establish a quality policy or audit procedures. The Eatontown, N.J., company, which makes air purification devices, did not conduct quality...

Published Thu, Apr 8 2010 0:16 by FoodSafetyNews

Tags: FDAnews – News
FDA Seeks Manufacturer Input on Transparency Project

The FDA has set an April 12 deadline for feedback on what the agency should do to improve communication and guidance development with manufacturers. The agency’s Transparency Task Force, in the third stage of its initiative, is focusing on ways to improve...

Published Wed, Apr 7 2010 0:05 by FoodSafetyNews

Tags: FDAnews – News
FDA: HMI Failed to Conduct Proper Quality System Audit

HMI Industries has been warned for good manufacturing practice violations related to its air-filtration devices, including failure to conduct quality audits. The Strongsville, Ohio, company’s audit procedure did not address the frequency of audits or...

Published Mon, Apr 5 2010 22:57 by FoodSafetyNews

Tags: FDAnews – News

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