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Home » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
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Medical Chemical Corp. Draws Form 483 for Lax Validations, Design Controls

June 9, 2022
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

Lincotek Medical Receives Form 483 for CAPA, Validation Issues

May 31, 2022
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

Vivorte Draws FDA Form 483 Over Multiple Sterilization Issues

May 27, 2022
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

Elite Biomedical Solutions Handed 483 for Complaint, Validation, Documentation Issues

May 26, 2022
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

S. Jackson Handed Form 483 for CAPA, Risk Analysis and Quality System Issues

May 17, 2022
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

Colorado Device Firm Shuts Down After Receiving Form 483

May 16, 2022
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

Pemco Draws Form 483 for Inadequate Validation and Design Changes

May 13, 2022
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 Gets Form 483 for CAPA, Complaint Issues

May 10, 2022
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

FDA Issues Microbiologics a Form 483 for Device Recall Reporting, Process Controls

May 6, 2022
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

Protom International Draws Form 483 for SOP, Documentation Lapses

May 5, 2022
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 Hands Suture Concepts a Form 483 For Incomplete Procedures and Records

May 4, 2022
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

Ray Vision Receives Form 483 Primarily for Documentation Issues

April 25, 2022
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
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