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Quality / Medical Devices

FDA Cites Four New York Firms Over Procedures, Records

June 28, 2017

The FDA flagged four New York-based device manufacturers, primarily for problems with procedures and record-keeping.

The FDA issued a Form 483 to Curbell Medical Products, citing its procedures for nonconforming products and corrective and preventive actions. Carestream Health, meanwhile, failed to document review and evaluation for corrective actions it took; the records for such actions do not address the potential impact of the problem in future units or document when certain corrections occurred.

The FDA hit pediatric device maker Hard Manufacturing for its procedures for design control, complaints and non-conforming products. Meanwhile, Dynarex was cited for incomplete design validation records, and for lacking a laboratory to issue Certificates of Analysis.

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