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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
The FDA has issued a nine-observation Form 483 to Sacks Holdings, based on an inspection last December of the company’s facility in San Diego, Calif. Read More
Gauthier Biomedical, a spinal and orthopedic surgical instrument manufacturer in Grafton, Wisc., has received a five-observation Form 483 from the FDA following an inspection in which the agency’s investigator observed several repeat deficiencies from a previous inspection in 2016. Read More
The FDA has issued a Form 483 to device developer Medical Solutions International, based on an inspection last December of the company’s manufacturing facility in Shawnee Mission, Kan. Read More
MichClone Associates, a medical device manufacturer in Troy, Mich., has received a seven-observation Form 483 from the FDA for deficiencies observed during an inspection late last year. Read More
The FDA has issued an 8-observation Form 483 to Hampton Medical Devices, based on an inspection last November of the company’s manufacturing facility in Festus, Mo. Read More