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An FDA inspection of Polar Products’ device manufacturing plant in Stow, Ohio, found that the facility lacked proper design and other records and did not adequately evaluate incoming product or its suppliers.
Logistics such as making sure only the right personnel have access to documents and that those documents can be copied, printed or scanned may seem basic but they are critical to a successful FDA inspection, says David L. Chesney, principal of DL Chesney Consulting. Read More
A large part of the FDA inspection process is reviewing documents and those documents need to be accessible promptly on request, according to an FDA inspections expert speaking at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
Complete document archives with self-explanatory file names are the top two — out of the top 10 — ways to be prepared for an FDA inspection, advised an FDA inspections expert at the WCG FDAnews Annual Inspections Summit in Washington, D.C., Nov. 16-18. Read More
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 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
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, 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, 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
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
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
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