# FDA 483 - TAKA USA, INC. dba Cosmetic Innovations - June 06, 2019

Source: https://www.globalkeysolutions.net/records/483/taka-usa-inc-dba-cosmetic-innovations/7136751b-fce6-46ba-a3d4-b21d2ada4e1f

> FDA 483 for TAKA USA, INC. dba Cosmetic Innovations on June 06, 2019. 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: 2019-06-06
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: TANO USA, INC. dba Cosmetic Innovations in Carrollton, TX, a contract manufacturer of OTC human topical drug products, was cited with seven observations during an FDA inspection. The firm lacked written procedures for its Quality Control Unit, failed to conduct finished product testing for identity and strength of active ingredients, and did not have a written stability testing program or adequate process validation studies. Additionally, deficiencies were noted in batch production records, cleaning validation, and the testing of active pharmaceutical ingredient components.

## Related Documents

- [WARNING_LETTER - 2019-06-06](https://www.globalkeysolutions.net/records/warning_letter/taka-usa-inc-dba-cosmetic-innovations/3e1a1e74-8e47-4cc4-956f-c6d23a1a911c)
- [483 - 2021-09-27](https://www.globalkeysolutions.net/records/483/taka-usa-inc-dba-cosmetic-innovations/30128193-27af-4dd4-84e5-e5c6ced94f8e)
- [483 - 2023-02-07](https://www.globalkeysolutions.net/records/483/taka-usa-inc-dba-cosmetic-innovations/abc21e08-c43c-4201-b5de-a7eab037fa42)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

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

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9