Warning letter

Kyowa Hakko Kogyo Co., Ltd. [ARCHIVED]: warning letter of Sep 29, 2010

FDA warning letter 127233 · Center for Drug Evaluation and Research

Key facts

Reference number 127233
Company Kyowa Hakko Kogyo Co., Ltd. [ARCHIVED]
Subject CGMP for Deviations/Adulterated
Issue date Sep 29, 2010
Posted date Sep 29, 2010
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Hofu
Inspection start date Jun 21, 2010
Letter on fda.gov web.archive.org

At a glance

  • 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:

Browse all FDA warning letters