Warning letter

International Science & Technology, L.P.: warning letter of Sep 27, 2001

FDA warning letter UCM178390 · Dallas District Office

Key facts

Reference number UCM178390
Company International Science & Technology, L.P.
Subject CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded
Issue date Sep 27, 2001
Posted date Sep 27, 2001
Issuing office Dallas District Office
Product type Devices
CFR sections cited 820.1, 820.40, 806.10(a), 820, 803.17, 806, 806.2(i), 803.18
Country 3
Inspection city Spring
Inspection ZIP 77380-1943
Inspection start date Aug 14, 2001
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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