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Medical Device Single Audit Program (MDSAP) regulatory authorities (RAs) have extended the program’s remote audit arrangements until Sept. 30. Read More
Wound Care Technologies, a provider of wound therapy systems, received a Form 483 from the FDA for inadequate inspection procedures for incoming products, as well as for its handling of complaints and medical device reporting (MDR). Read More
The FDA hit Heany Industries, a manufacturer of industrial ceramics and thermally based coatings, with a Form 483 for inadequate validations and corrective and preventive action (CAPA) procedures after an inspection of its Scottsville, N.Y., facility in March. Read More
Angel Medical Systems, a device company that offers an implantable cardiac monitoring and alerting system, was hit with a Form 483 for corrective and preventive action (CAPA) and documentation lapses observed during a March inspection of its Eatontown, N.J., facility. Read More
The FDA issued Photonic Health an eight-observation Form 483 after an inspection of the company’s Ocala, Fla., facility in March found the firm had failed to address deficiencies observed in a previous inspection. Read More
The FDA issued Stand Aid of Iowa a Form 483 that listed several deficiencies seen in previous inspections, including inadequate procedures for nonconforming products and for assigning serial numbers to finished devices. Read More
The FDA issued American Contract Systems a Form 483 that listed several deficiencies seen in previous inspections, including lax validations and “ineffective” corrective and preventive actions (CAPA). Read More
The FDA handed Medical Chemical Corp. a Form 483 for not following its own written procedures after an inspection of the company’s Torrance, Calif., facility in March. Read More
An FDA investigator handed Lincotek Medical a Form 483 for inadequate corrective and preventive action (CAPA) and validation procedures after an inspection last November of the company’s facility in Vandalia, Ohio. Read More
The FDA smacked Louisville, Ky.-based devicemaker Vivorte with a Form 483 over sterilization lapses observed during an inspection conducted from Nov. 15 to 23, 2021. Read More
The FDA has issued a Form 483 to Elite Biomedical Solutions citing problems with its complaint records, process and nonconforming product documentation, and validation procedures. Read More
Virginia-based device manufacturer S. Jackson received a Form 483 for repeat corrective and preventive action (CAPA) and risk analysis deficiencies following a December inspection by the FDA of its Alexandria facility. Read More