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- Owens Minor, Inc. dba American Contract Systems, Inc . . .
All finished goods in ACS manufacturing locations and O M distribution centers were then placed on distribution hold on August 7, 2024, while you investigated these failures
- Contract sterilizer of devices draws FDA warning over . . .
FDA sent a warning letter to contract sterilizer American Contract Systems after finding its Houston, Texas facility noncompliant with good manufacturing practices, the agency disclosed Tuesday
- FDA Dashboards - Compliance Actions
Compliance data provide information on a subset of the actions used by the FDA to bring firms into compliance, specifically data pertaining to Warning Letters, Seizures, and Injunctions
- Class 2 Device Recall American Contract Systems (ACS)
American Contract Systems issued Urgent Voluntary Recall Letter (FA-2024-018) via email on 5 15 24 to Distributors Distributors to notify end-users
- FDA Warning Letters – Association of Food and Drug Officials
Explore FDA’s comprehensive resources to understand different warning letter types, learn from real examples, and discover best practices for responding to FDA concerns
- ACS Dobfar Warning Letter Enumerates Contamination Concerns
FDA cites the contract drug manufacturer's"significant deviations" from U S current good manufacturing practices
- Warning Letters | FDA
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