# FDA WARNING_LETTER - Kyowa Hakko Kogyo Co., Ltd. - June 25, 2010

Source: https://www.keypedia.com/records/warning_letter/kyowa-hakko-kogyo-co-ltd/e3ea7270-71b9-4568-9475-c993da908445

> FDA WARNING_LETTER for Kyowa Hakko Kogyo Co., Ltd. on June 25, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Kyowa Hakko Kogyo Co., Ltd.
- Inspection Date: 2010-06-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Kyowa Hakko Kogyo Co., Ltd. (now Kyowa Hakko Bio Co., Ltd.) on September 29, 2010, following a June 21-25, 2010, inspection of their API manufacturing facility in Hofu City, Japan. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP), rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's July 14, 2010, response was deemed insufficient.

Key violations included:
1.  **Failure to thoroughly investigate OOS results:** Incomplete documentation and insufficient scope of investigations into high impurity levels and laboratory errors.
2.  **Inadequate sampling and test procedures:** Chromatographic methods lacked system suitability tests, and incoming material sampling was scientifically unsound and not performed by the firm.
3.  **Unvalidated stability-indicating analytical methods:** The method for testing API stability was not validated to be stability-indicating, with incomplete forced degradation studies.
4.  **Improper analytical method validation and modification assessment:** The API assay method lacked essential validation elements, and gradient changes were made without re-validation.
5.  **Lack of control system for laboratory records:** Repeat observation from a 2007 inspection; raw data was not recorded in controlled, unique-

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