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Failure to resolve at least six of 10 observations from an earlier inspection resulted in another Form 483 in January for Theweb2u.com, maker of the Therapik insect bite and itch relief device. Read More
A Form 483 cites Cocoa Beach, Fla.-based Ward Photonics for continuing problems with investigation and evaluation of customer complaints for possible medical device report (MDR) requirements. Read More
Maiden Biosciences received a Form 483 for quality system lapses after the FDA inspected the company’s Gaithersburg, Md., facility in November 2022. Read More
The FDA handed Sea-Long Medical Systems a warning letter on April 4 for failing to notify the agency of expanded indications for its treatment hood device. Read More
Device manufacturers that apply a more risk-based framework to corrective and preventive action (CAPA) plans rather than using the more typical one-size-fits-all approach could see reduction of up to 80 percent in the time required to implement improvements. Read More
Significantly modifying its Velopex Aquacut fluid abrasion unit in multiple ways without submitting a new 510(k) clearance application has resulted in the UK’s Medivance Instruments receiving a Feb. 13 warning letter from the FDA. Read More
The FDA’s Office of Regulatory Affairs (ORA) needs technological advances to create “one source of truth” rather than the siloed data systems that currently hamper its efforts to modernize inspectional work, according to its chief. Read More
Double-checking that a Form 483 is factually correct — and that the observations make sense — are two of the most important things a firm can do when given the document, said inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar. Read More
The FDA has told Fullerton, Calif.-based Synovo Production to cease manufacture of its hip cup replacement system because the company failed to notify the agency about significant changes to the product. Read More
Burlington, Mass.- based LeMaitre Vascular drew a lengthy Form 483 from the FDA for failing to follow the company’s own corrective and preventive action (CAPA) procedure and to control nonconforming product, among other lapses.
The FDA has issued a warning letter to Tokyo-based endoscope manufacturer Olympus Medical Systems for failing to establish procedures to implement corrective and preventative actions as well as a lack of process validation for product changes, among other lapses.
North Carolina-based Carolina Biological Supply was handed a Form 483 for lacking adequate procedures for corrective and preventative actions (CAPA), medical device reporting (MDR) and audits, among other lapses.
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