483
MekoFDA 483 - Meko - February 21, 2019
Record Details
An FDA inspection of Meko, a medical device manufacturer in Sarstedt, Germany, revealed significant quality system deficiencies. The firm failed to adequately control nonconforming products and did not follow its own procedures for initiating nonconformance reports. Additionally, quality audits were conducted by personnel with direct responsibility for the audited areas, compromising auditor independence.
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ID · 64f738d5-3264-4943-bad7-73d76c4e35ef
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