Warning letter

I. Shay Cosmetics Inc: warning letter of Oct 29, 2018

FDA warning letter 552754 · San Francisco District Office

Key facts

Reference number 552754
Company I. Shay Cosmetics Inc
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Oct 29, 2018
Posted date Nov 20, 2018
Issuing office San Francisco District Office
Product type Drugs
CFR sections cited 211.34, 211.192, 211.22(a), 211.84(d)(1), 211.165(a), 211.166(a)
Inspection city Harbor City
Inspection ZIP 90710
Inspection start date Nov 27, 2017
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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