# FDA 483 - Outin Futures Corp - August 12, 2022

Source: https://www.keypedia.com/records/483/outin-futures-corp/d5e94fad-0bfe-489f-a155-e7414633951e

> FDA 483 for Outin Futures Corp on August 12, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Outin Futures Corp
- Inspection Date: 2022-08-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Outin Futures Corp., a manufacturer in Chungju, Korea, was cited for multiple significant deficiencies in its manufacturing practices for OTC drug products. The inspection revealed severe issues across training, stability studies, laboratory controls, in-process material management, equipment cleaning, and process validation, with several repeat observations indicating a systemic lack of adherence to cGMP regulations.

## Related Officers

- [Investigator](https://www.keypedia.com/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)

Company: https://www.keypedia.com/companies/outin-futures-corp/be688c74-4b65-47f5-8fae-4a1ec11e21da

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