# FDA 483 - Tsukioka Film Pharma Co., Ltd. - May 24, 2019

Source: https://www.keypedia.com/records/483/tsukioka-film-pharma-co-ltd/3909cbdc-b3bc-4084-970f-c577238d4291

> FDA 483 for Tsukioka Film Pharma Co., Ltd. on May 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tsukioka Film Pharma Co., Ltd.
- Inspection Date: 2019-05-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Tsukioka Film Pharma Co., Ltd. in Kakamigahara, Gifu, Japan, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate out-of-specification (OOS) investigations, unvalidated test methods for impurities, and poorly maintained equipment. These issues indicate a failure to ensure the quality, purity, and safety of drug products distributed to the United States.

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.keypedia.com/companies/tsukioka-film-pharma-co-ltd/f1b8c995-2313-4a17-b88a-6663cb7504c5

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1