Warning letter

RLC Labs Inc.: warning letter of Oct 9, 2020

FDA warning letter 607596 · Division of Pharmaceutical Quality Operations IV

Key facts

Reference number 607596
Company RLC Labs Inc.
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Oct 9, 2020
Posted date Oct 20, 2020
Issuing office Division of Pharmaceutical Quality Operations IV
Product type Drugs
CFR sections cited 211.100(a), 207, 211.34, 312, 211.22(a), 211.84(d)(2), 211.166(a), 600.3(h)(6)
Inspection city Phoenix
Inspection ZIP 85034-6703
Inspection start date Feb 20, 2020
Letter on fda.gov fda.gov

At a glance

  • 1–9 CFR sections cited
  • 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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