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Failure to adhere to regulations covering production and process control procedures is the most common observation documented by FDA investigators during pharmaceutical facility inspections, according to an agency analysis of recent Form 483 reports.
The FDA recently issued warning letters to two Asian manufacturers found to be in violation of current good manufacturing practice (cGMP) requirements.
Larry Pilot, a partner at the Washington, D.C.-based law firm of McKenna, Long & Aldridge, has petitioned the FDA to remove a misleading statement from Form 483s that infers the quality system regulation (QSR) requires devicemakers to identify and correct violations.
The FDA has issued a warning letter to Dublin, Calif.-based Obsidian Medical Technology for allegedly violating numerous good manufacturing practice requirements of the quality system regulation (QSR).
The failure of a U.S. cardiac monitor manufacturer to document the most basic elements of design and quality control in its medical device reporting has attracted the FDA’s attention.
The FDA concluded its inspection of Utah Medical Products (UTMD) on March 3 by issuing the company a Form 483 citing seven violations of the agency’s quality system regulation (QSR).
A botched series of inspections may be to blame for the budding rift between the FDA and Utah Medical Products (UTMD), according to Edward McDonnell, the former district director of the FDA’s New England District.
PhRMA believes time limitations defined in an FDA draft guidance on dispute resolution (DR) would place manufacturers at a disadvantage when using the system or result in dispute resolution requests that are incomplete.
Various neonatal chemistry systems and Immunoisoelectric focusing diagnostic kits manufactured by PerkinElmer Life Sciences were seized last week after the FDA repeatedly warned the company to correct numerous quality system violations at its Norton, Ohio facility where the products are manufactured.