Warning letter

K S Choi Corp: warning letter of May 17, 2013

FDA warning letter 393574 · Los Angeles District Office

Key facts

Reference number 393574
Company K S Choi Corp
Subject CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated
Issue date May 17, 2013
Posted date May 17, 2013
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 807.81(b), 803.17, 803, 807.81(a)(3)(ii), 820
Inspection city Los Angeles
Inspection ZIP 90037
Inspection start date Dec 11, 2012
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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