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Home » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
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FDA Investigators Relentless in Pursuit of Data Integrity Issues, Experts Say

November 21, 2022
The integrity of manufacturers’ data is a major focus of FDA inspections and the agency’s investigators will go to great lengths to uncover problems, three former FDA inspection officials told attendees at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C. last week. Read More

DeVilbiss Healthcare Draws 483 for Complaint Handling, Design Verification

November 17, 2022
DeVilbiss Healthcare received a Form 483 from the FDA for inadequate complaint handling, design verification and lack of corrective and preventive action (CAPA) procedures, following an Aug. 1-17 inspection of its Somerset, Pa., facility. Read More

RightEye Receives Form 483 for Lax Design Controls and Other Failings

November 9, 2022
Eye movement tracking technology developer RightEye got a Form 483 for lapses in its design controls, product handling and complaint procedures, among other deficiencies observed during a June 28 to July 8 FDA inspection of its Bethesda, Md., facility. Read More

Mytrex Gets 483 for Lack of Testing, Documentation, Procedures

November 8, 2022
Mytrex, a manufacturer of personal emergency response systems, received a Form 483 from the FDA for lack of equipment testing and inadequate recordkeeping, among other lapses observed during an inspection of the company’s South Jordan, Utah, facility. Read More

Wintech Medipro Rapped for Numerous Observations During Inspection

November 7, 2022
Wintech Medipro, a manufacturer of surgical and medical face masks in Katy, Texas, has drawn a Form 483 for a host of observations, including inadequate complaint handling, medical device reporting and employee training. Read More

FDA Hands Rockwell Medical a Form 483 for CAPA and Equipment Issues

November 4, 2022
Rockwell Medical received a Form 483 after the FDA observed inadequate corrective and preventive actions (CAPA) and equipment maintenance problems in a July inspection of the company’s Grapevine, Texas, facility. Read More

RetroFix Rapped for Lax Design Controls, Validations

November 1, 2022
The FDA issued a Form 483 to RetroFix Screws for inadequate design controls and other deficiencies observed during an inspection of the company’s facility in Salisbury, N.C. Read More

Harmar Mobility Lands 483 for Lack of Documentation

October 25, 2022
The FDA issued Harmar Mobility a Form 483 for inadequate design validation procedures and other lapses observed at the company’s Lake Winnebago, Mo., facility during a July 11-15 inspection. Read More

Medicated Patch Firm Rapped for Inadequate Testing, Validation Procedures

October 21, 2022
The FDA handed Akron Coating & Adhesives a Form 483 for not properly testing or controlling combination drug-device products at its Akron, Ohio, facility. Read More

Forcemech Draws Warning Letter for Missing UDIs, Faulty Control Procedures

October 20, 2022
The FDA has issued a warning letter to Forcemech International in Pearland, Texas, after not getting a response to observations it made during an inspection from March 29 to April 4. Read More

Inadequate Complaint and Quality Procedures Lands Hill Laboratories a Form 483

October 19, 2022
An FDA inspection of Hill Laboratories’ Frazer, Penn., facility found problems with complaint and audit procedures as well as the design of a light therapy unit. Read More

Advanced Facialdontics Rapped for Missing Device History, Quality and MDR Procedures

October 17, 2022
The FDA issued Advanced Facialdontics a Form 483 for lacking a complete design history file and other deficiencies observed during an inspection of the company’s East Islip, N.Y., facility in July. Read More
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