Warning letter

Sanitor Corporation: warning letter of Nov 29, 2021

FDA warning letter 616232 · Division of Pharmaceutical Quality Operations IV

Key facts

Reference number 616232
Company Sanitor Corporation
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Nov 29, 2021
Posted date Dec 14, 2021
Issuing office Division of Pharmaceutical Quality Operations IV
Product type Drugs
CFR sections cited 201.61, 201.128, 207, 207.41, 211.22, 211.34, 207.41(c)(1), 207.41(c)(2), 211.68(b), 211.160(b)
Inspection city Stanton
Inspection ZIP 90680
Inspection start date May 25, 2021
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:

Browse all FDA warning letters