# FDA 483 - Nippon Shikizai, Inc. - September 12, 2025

Source: https://www.keypedia.com/records/483/nippon-shikizai-inc/07164b4c-517c-4882-8b5b-0c63ff12a91d

> FDA 483 for Nippon Shikizai, Inc. on September 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nippon Shikizai, Inc.
- Inspection Date: 2025-09-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: During an inspection conducted from September 8-12, 2025, the FDA issued a Form 483 to Nippo Shikizai, Inc., Tsukuba Factory, citing several observations related to their manufacturing practices for drug products. The observations highlight concerns regarding compliance with Current Good Manufacturing Practices (cGMP).

Key issues included deficiencies in the firm's cleaning validation procedure, specifically its exclusion of certain products and lack of established hold times for equipment. This was noted as a repeat observation. Furthermore, the inspection revealed inadequate investigation and invalidation of Out-Of-Specification laboratory results, with instances where results were dismissed as laboratory errors without sufficient scientific justification.

Other observations noted incomplete identity testing for incoming components, relying solely on methods like Infrared Absorption spectrometry without incorporating more specific tests. Equipment logs were found to lack essential details such as product, time, and lot numbers for each batch. The company also failed to justify deviations from written production procedures, with process validation reports not fully evaluating all manufacturing steps. Finally, the stability program was deemed deficient as it did not require representative samples of all OTC drug products manufactured annually to be included in stability studies.

Nippo Shikizai, Inc. is expected to promptly address these observations by developing and implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards.

## Related Officers

- [investigator](https://www.keypedia.com/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

Company: https://www.keypedia.com/companies/nippon-shikizai-inc/3c12bd96-80ba-4b34-8492-72de16d6e6f3

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8