Warning letter

Master Paints & Chemicals Corp.: warning letter of Mar 13, 2024

FDA warning letter 672462 · Division of Pharmaceutical Quality Operations II

Key facts

Reference number 672462
Company Master Paints & Chemicals Corp.
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Mar 13, 2024
Posted date Apr 16, 2024
Issuing office Division of Pharmaceutical Quality Operations II
Product type Drugs
CFR sections cited 211.22, 211.34, 211.67(a), 211.84(d)(1), 211.100(a), 211.165(a), 211.166(a)
Inspection city Guayanilla
Inspection ZIP 00656
Inspection start date Oct 11, 2023
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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