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Home » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
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CooperSurgical Hit with Form 483 for IUD Manufacturing Issues

July 14, 2022
Devicemaker CooperSurgical, a division of CooperCompanies, was slapped with a five-observation Form 483 for manufacturing problems primarily focused on its intrauterine device (IUD) Paragard T380A copper contraceptive. Read More

W.H.P.M. Gets Warning Letter for Unapproved COVID-19 Test Kits

July 14, 2022
Irwindale, Calif.-based W.H.P.M has received a warning letter from the FDA for distributing unapproved COVID-19 tests in the U.S. Read More

FDA Cites Texas Medical for a Wide Range of Issues in Form 483

July 12, 2022
Texas Medical Technology received a Form 483 from the FDA for a variety of lapses observed during a Feb. 16 to March 3 inspection at its Houston facility, ranging from inadequate device records to ineffective medical device reporting (MDR) procedures. Read More

C&A Tool Hit for Production Procedures and Other Quality Issues

July 11, 2022
C&A Tool’s Auburn, Ind. device manufacturing facility received a Form 483 from the FDA for good manufacturing practice issues and other deficiencies observed during a Feb. 28 to March 3 inspection. Read More

FDA Raps Seno Medical Instruments for Design Control Procedures, Validations

July 8, 2022
Seno Medical Instruments received a Form 483 after the FDA inspected its San Antonio, Texas, facility last February and March, listing inadequate design control procedures and other lapses. Read More

MDSAP Remote Audit Measures Extended Until Sept. 30

July 5, 2022
Medical Device Single Audit Program (MDSAP) regulatory authorities (RAs) have extended the program’s remote audit arrangements until Sept. 30. Read More

Wound Care Technologies Gets Form 483 for Inadequate Inspection, Complaint, MDR Procedures

June 28, 2022
Wound Care Technologies, a provider of wound therapy systems, received a Form 483 from the FDA for inadequate inspection procedures for incoming products, as well as for its handling of complaints and medical device reporting (MDR). Read More

Heany Industries Gets Form 483 for Inadequate Validations, CAPAs

June 27, 2022
The FDA hit Heany Industries, a manufacturer of industrial ceramics and thermally based coatings, with a Form 483 for inadequate validations and corrective and preventive action (CAPA) procedures after an inspection of its Scottsville, N.Y., facility in March. Read More

Angel Medical Systems Draws 483 for CAPA, Documentation Issues

June 24, 2022
Angel Medical Systems, a device company that offers an implantable cardiac monitoring and alerting system, was hit with a Form 483 for corrective and preventive action (CAPA) and documentation lapses observed during a March inspection of its Eatontown, N.J., facility. Read More

Photonic Gets 483 for Repeat Deficient Design, CAPA and MDR Procedures

June 21, 2022
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

Stand Aid of Iowa Rapped for Lax Procedures, History Records

June 14, 2022
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

American Contract System’s Problems With Validation, CAPA Persist

June 10, 2022
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
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