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# Testing Deficiencies Cited at Asahi Kasei Finechem API Plant
- URL: https://www.fdaweb.com/testing-deficiencies-cited-at-asahi-kasei-finechem-api-plant/
- Published: 2026-01-23T12:00:00.000Z
- Updated: 2026-09-14T15:31:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160535

FDA has cited Asahi Kasei Finechem Co. for significant quality control deficiencies following a November inspection of the company’s active pharmaceutical ingredient (API) manufacturing facility in Japan. According to an FDA inspection report, the facility failed to ensure that analytical testing methods used for finished product release met required standards of accuracy and reliability. Investigators determined that the company had not performed validation studies on certain in-house analytical methods, nor had it adequately verified United States Pharmacopeia (USP) methods used to test drug products manufactured for the U.S. market.

The agency cited several examples of unvalidated in-house methods, including tests for heavy metals, *E. coli*, and *Salmonella* species used in finished product release testing. In addition, FDA identified multiple USP methods — such as loss on drying and infrared identification tests — that were used without proper method verification.

“These failures compromise the firm’s ability to demonstrate that test results accurately reflect product quality and compliance with specifications,” the [FDA Form 483](https://www.fda.gov/media/190692/download?ref=fdaweb.com) said.