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Vancouver-based RS Medical was handed a 483 following a February inspection that found CAPA procedures and validation activities lacking. The company manufactures electrotherapy pain products. Read More
Failure to control its production processes and to validate them properly landed devicemaker Oscor an FDA warning letter for quality system deficiencies. Read More
Renovis Surgical Technologies received a strong warning from the FDA over its failure to conform to quality system regulations covering design verification, process validation, product development requirements and risk analysis. Read More
Fluke Biomedical was handed a five-observation Form 483 because it failed to properly select any of the suppliers for its CLEAR-Pb X-Ray shielding products. Read More
Zimmer Biomet had hinted at a warning letter in an SEC filing last month but revealed little details about the exact nature of the deficiencies uncovered at the firm’s facility in Montreal, Canada. Read More
Failure to establish procedures for quality audits and management reviews landed C-PAP maker Somnowell a May 12 warning letter for numerous quality system violations. Read More