Warning letter

Clean Solutions LLC: warning letter of Sep 6, 2024

FDA warning letter 686995 · Division of Pharmaceutical Quality Operations I

Key facts

Reference number 686995
Company Clean Solutions LLC
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Sep 6, 2024
Posted date Oct 1, 2024
Issuing office Division of Pharmaceutical Quality Operations I
Product type Drugs
CFR sections cited 211.34, 211.22(d), 211.67(a), 211.84(d)(1), 211.100(a), 211.165(a), 211.180(e), 211.166(a), 211.188(b), 211.22
Inspection city Clifton
Inspection ZIP 07011
Inspection start date May 6, 2024
Letter on fda.gov fda.gov

At a glance

  • 10–99 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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