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

BioVision Technologies, a Boulder, Colo.-based device company, has shut down in the wake of an FDA inspection that observed multiple failures in procedures, controls and documentation. Read More

Inadequate procedures for validations, design changes and complaints were spelled out in a five-observation Form 483 handed to Pemco, a cardiothoracic surgical devicemaker, after an inspection of its facility in Independence, Ohio last December. Read More

MIVI Neuroscience received a Form 483 with three observations for inadequate corrective and preventive action (CAPA) activities and documentation issues observed during an FDA inspection of the company’s facility in Eden Prairie, Minn., last December. Read More

The FDA has handed Microbiologics a Form 483 for not reporting device recalls and not properly documenting process controls, following an inspection of the company’s facility in Saint Cloud, Minn., in November and December. Read More

The FDA issued ProTom International a Form 483 with eight observations following an inspection of the company’s manufacturing plant in North Reading, Mass., last December. Read More

FDA investigators issued a four-observation Form 483 to Suture Concepts, a manufacturer of soft-tissue management devices, following a December inspection of the company’s Beverly, Mass., facility. Read More

The FDA has handed Ray Vision an 11-observation Form 483 after an inspection of the ophthalmic equipment company’s Lake Forest, Calif., facility identified various documentation and other lapses. Read More