# TAKA USA, INC. – FDA 483, Feb 7, 2023

Source: https://www.keypedia.com/records/483/taka-usa-inc/abc21e08-c43c-4201-b5de-a7eab037fa42

> FDA 483 for TAKA USA, INC. on February 07, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TAKA USA, INC.
- Inspection Date: 2023-02-07
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: TAKA USA, INC. dba Cosmetic Innovations, a contract manufacturer in Coppell, TX, was cited with nine observations during an FDA inspection, indicating significant deficiencies across its manufacturing and quality control systems for OTC drug products. The firm failed to ensure proper product release testing, lacked process validation, maintained incomplete batch records, and had inadequate laboratory controls and employee training. These findings highlight a broad non-compliance with current good manufacturing practices.

## Related Documents

- [483 - 2021-09-27](https://www.keypedia.com/records/483/taka-usa-inc/30128193-27af-4dd4-84e5-e5c6ced94f8e) — date: September 27, 2021
- [483 - 2019-06-06](https://www.keypedia.com/records/483/taka-usa-inc/7136751b-fce6-46ba-a3d4-b21d2ada4e1f) — date: June 6, 2019
- [WARNING_LETTER - 2019-06-06](https://www.keypedia.com/records/warning_letter/taka-usa-inc/3e1a1e74-8e47-4cc4-956f-c6d23a1a911c) — date: June 6, 2019

## Related Officers

- [Shelby N. Turner](https://www.keypedia.com/people/shelby-n-turner/77268f33-ae48-4e30-abad-4d79c1077185)
- [Michelle A. Krayer](https://www.keypedia.com/people/michelle-a-krayer/c68b88a6-d3d3-4407-867b-81b92b7ce977)

Company: https://www.keypedia.com/companies/taka-usa-inc/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