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Home » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
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Sacks Holdings Draws Form 483 for Multiple Quality Deficiencies

April 21, 2022
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 Receives Form 483 for Several Repeat Deficiencies

April 19, 2022
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

Device Facility in Kansas Draws Form 483 for Documentation, CAPA Observations

April 1, 2022
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 Cited for Missing Procedures and Documentation

March 31, 2022
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

Hampton Medical Devices Receives Form 483 for Repeated Production Issues

March 29, 2022
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

Enthermics Medical Systems Receives a Form 483 for CAPA, Validation Lapses

March 15, 2022
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

TEI Biosciences Cited for Lax Monitoring, Adverse Event Reports

March 10, 2022
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

Lonza Facility in Maryland Rapped for CAPAs, Complaints

March 1, 2022
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

FDAnews Webinar Highlights Drawbacks to Remote Inspections

February 28, 2022
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

Becton Dickinson Facility Rapped for CAPAs, Complaints

February 25, 2022
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

Cleveland Diagnostics Draws Form 483 for Validation Lapses

February 24, 2022
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

FDA Again Delays In-Person Inspections Due to Omicron Concerns

January 21, 2022
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
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