# FDA 483 - TAKA USA, INC. dba Cosmetic Innovations - September 27, 2021

Source: https://www.keypedia.com/records/483/taka-usa-inc-dba-cosmetic-innovations/30128193-27af-4dd4-84e5-e5c6ced94f8e

> FDA 483 for TAKA USA, INC. dba Cosmetic Innovations on September 27, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TAKA USA, INC. dba Cosmetic Innovations
- Inspection Date: 2021-09-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: TAKA USA, INC. dba Cosmetic Innovations in Coppell, TX, an OTC drug manufacturer, was inspected by the FDA from September 20-27, 2021. The inspection revealed significant deficiencies across multiple systems, including a lack of personnel training, inadequate quality control unit procedures, and insufficient testing and process validation for OTC drug products. These issues indicate a broad failure to adhere to current good manufacturing practices.

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## Related Officers

- [Michelle A. Krayer](https://www.keypedia.com/people/michelle-a-krayer/c68b88a6-d3d3-4407-867b-81b92b7ce977)
- [Retired](https://www.keypedia.com/people/ariel-cruz-figueroa/c6ade050-dbe1-4aa3-b88f-980db51b88b0)

Company: https://www.keypedia.com/companies/taka-usa-inc-dba-cosmetic-innovations/b5688fbb-faaa-4716-93f5-37cce7b85f23

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab