We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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