Warning letter

American Cleaning Solutions: warning letter of Sep 6, 2022

FDA warning letter 632881 · Division of Pharmaceutical Quality Operations I

Key facts

Reference number 632881
Company American Cleaning Solutions
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Sep 6, 2022
Posted date Oct 18, 2022
Issuing office Division of Pharmaceutical Quality Operations I
Product type Drugs
CFR sections cited 211.22, 211.192, 211.67(b), 211.84(d)(1), 211.100(a), 211.165(a), 211.166(a), 211.180(e)
Inspection city Long Island City
Inspection ZIP 11101
Inspection start date Mar 7, 2022
Letter on fda.gov fda.gov

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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