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Companies that deliver prompt, convincing responses to an FDA Form 483 observation can minimize the impact of a negative assessment, according to a consultant, who added that communications failures early in the process can lead to serious enforcement actions against an offending firm.
An inspection of Lifecore Biomedical's facility in Chaska, Minn., from April 29 to May 17 has prompted the FDA to issue a warning letter concerning the company's Gynecare Intergel Adhesion Prevention Solution.
Fischer Industries, a maker of X-ray film processors, recently received a warning letter from the FDA citing failures to keep records of device corrections or removals.
The FDA issued a Sept. 22 warning letter to devicemaker Daavlin Distribution following an inspection that revealed numerous deficiencies, ranging from management shortcoming to inadequate quality audits.
Drug and device companies need to understand that their responses to Form 483 observations can affect the FDA's perception of an entire firm's operations, according to a consultant who specializes in the area.
The FDA issued a Sept. 8 warning letter to California-based General Medical Company following an inspection that revealed the firm’s manufacturing practices were not in conformity with the quality system (QS) regulation.
The FDA issued a warning letter to generics firm Bigmar-Bioren SA last month after uncovering significant cGMP deviations at its manufacturing plant in Barbengo, Switzerland.
Diagnostics manufacturer BioMerieux was recently slapped with an FDA warning letter documenting at least 10 violations of current good manufacturing practices (cGMPs).