Warning letter

Newton Laboratories Inc DBA Newton Homeopathics: warning letter of Apr 23, 2019

FDA warning letter 559612 · Division of Pharmaceutical Quality Operations II

Key facts

Reference number 559612
Company Newton Laboratories Inc DBA Newton Homeopathics
Subject CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Issue date Apr 23, 2019
Posted date Apr 30, 2019
Issuing office Division of Pharmaceutical Quality Operations II
Product type Drugs
CFR sections cited 211.34, 211.192, 211.67(a), 211.100(a), 211.180(e)
Inspection city Conyers
Inspection ZIP 30013
Inspection start date Mar 26, 2018
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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