483
Acme Monaco CorporationFDA 483 - Acme Monaco Corporation - April 17, 2019
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Record Details
An FDA inspection of Acme Monaco Corporation, a medical device manufacturer in New Britain, CT, revealed significant deficiencies in their quality system. Observations included device history records not demonstrating manufacturing in accordance with device master records, specifically regarding product specifications and coating verification. Additionally, the firm failed to adequately establish and log schedules for equipment cleaning and maintenance.
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ID · 97850888-13d0-4936-91a4-32e9d67b449b