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

The FDA has issued a Form 483 to Enthermics Medical Systems, based on an inspection last September of the company’s facility in Menomonee Falls, Wis. Read More

Integra LifeScience’s TEI Biosciences drew a six-observation Form 483 from the FDA based on an inspection last October and November of the company’s facility in Boston, Mass. Read More

The FDA has issued a Form 483 to medical device and biologics manufacturer Lonza based on an inspection last November of the company’s facility in Walkersville, Md. Read More

An FDA remote inspection can carry major drawbacks, including that they may last longer than an in-person visit and that the FDA doesn’t consider them to be a full substitute for an on-site inspection. Read More

The FDA has issued a Form 483 to Becton Dickinson (BD) Caribe based on an inspection last November of the devicemaker’s facility in Juncos, Puerto Rico. Read More

Medical diagnostic test developer Cleveland Diagnostics has received a Form 483 for deficiencies observed during an FDA inspection of the company’s facility in Cleveland, Ohio, last November. Read More

The FDA has extended its delay on conducting in-person domestic surveillance in-spections through Feb. 4 with the goal of restarting the activities as soon as safely pos-sible. Read More