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A Jackson, Miss., devicemaker received a 16-count Form 483 from the FDA’s Detroit district office after an inspection found major problems with the company’s risk analysis, testing procedures and employee training. Some of the observations were repeated from a 2012 inspection. Read More
A contact lens manufacturer that failed to respond to a Form 483 in February following an FDA inspection now must respond to a warning letter. Read More
Internal audits can be a great way for a devicemaker to uncover quality issues and improve compliance programs, but there are challenges to doing them. The vast majority of manufacturers conduct internal audits soley because the FDA and ISO regulations say they should, says Susan Reilly, owner of the consultancy Reilly & Associates. That results in poorly conducted audits with little or no added value. During a recent FDAnews webinar, Reilly answered questions about how to design and perform effective internal audits. Read More
A Jackson, Miss., devicemaker received a 16-count Form 483 from the FDA’s Detroit district office after an inspection found major problems with the company’s risk analysis, testing procedures and employee training. Some of the observations were repeated from a 2012 inspection. Read More
Inspectors from the FDA’s Florida district office found a pattern of missing or faulty records of supplier audits at a Clearwater, Fla.-based Soft Computer Consultants, leading to an eight-observation Form 483 for the company. The company also received a Warning Letter from the FDA. Read More
BD’s CareFusion subsidiary issued an update on its recall of the Avea ventilator to provide clarification on certain units of the product. The device is intended for continuous breathing support in infants through adults. Read More
A Virginia maker of implants used in plastic surgery was slapped with a warning letter after an FDA inspection found flaws with the company’s validation and MDR reporting practices. Read More
The FDA issued a warning letter to Thermedx, a Solon, Ohio-based manufacturer of gynecological and urological fluid management systems, for failing to notify the agency of device upgrades and other GMP violations. Read More
The FDA banned imports of Doro’s Evacu B wheeled stretchers for infants, after a Nov. 10 to 13, 2014, inspection found serious GMP violations that were noted in a Form 483 to the company. Read More
Internal audits can be a great way for a devicemaker to uncover quality issues and improve compliance programs, but there are challenges to doing them. The vast majority of manufacturers conduct internal audits soley because the FDA and ISO regulations say they should, says Susan Reilly, owner of the consultancy Reilly & Associates. That results in poorly conducted audits with little or no added value. During a recent FDAnews webinar, Reilly answered questions about how to design and perform effective internal audits.Read More