Warning letter

Micro Labs Limited: warning letter of Jan 9, 2015

FDA warning letter 437438 · Center for Drug Evaluation and Research

Key facts

Reference number 437438
Company Micro Labs Limited
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Jan 9, 2015
Posted date Feb 3, 2015
Issuing office Center for Drug Evaluation and Research
Product type Drugs
CFR sections cited 211.68(b), 211.160(a), 211.194(a), 314.81(b)(1)(i), 314.81(b)(1)(ii)
Inspection city Verna
Inspection start date May 5, 2014
Letter on fda.gov web.archive.org

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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