Warning letter

Diasol East, Inc.: warning letter of Jul 12, 2017

FDA warning letter 522511 · Florida District Office

Key facts

Reference number 522511
Company Diasol East, Inc.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jul 12, 2017
Posted date Oct 3, 2017
Issuing office Florida District Office
Product type Devices
CFR sections cited 820, 820.40
Inspection city Watertown
Inspection ZIP 37184
Inspection start date Feb 21, 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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