Warning letter

American Contract Systems [ARCHIVED]: warning letter of Apr 21, 2011

FDA warning letter 164433 · Cincinnati District Office

Key facts

Reference number 164433
Company American Contract Systems [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Apr 21, 2011
Posted date Apr 21, 2011
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 803, 803.17, 820
Inspection city Tiffin
Inspection ZIP 44883
Inspection start date Jan 5, 2011
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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