# FDA 483 - Creative Essences Inc - March 25, 2025

Source: https://www.keypedia.com/records/483/creative-essences-inc/733e3cfd-7f1c-43a6-bdd7-d3ccfa7ecc66

> FDA 483 for Creative Essences Inc on March 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creative Essences Inc
- Inspection Date: 2025-03-25
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Creative Essences Inc, a drug manufacturer in Santa Fe Springs, CA, was inspected by the FDA from March 19-25, 2025. The inspection revealed significant deficiencies across quality, laboratory, materials, facilities, equipment, and production systems, many of which were repeat observations from a previous 2020 inspection. Key issues include inadequate investigations, lack of proper quality control procedures, insufficient employee training, unconfirmed stability data for drug products, and unvalidated cleaning and manufacturing processes.

## Related Documents

- [483 - 2020-09-04](https://www.keypedia.com/records/483/creative-essences-inc/553361d2-5ee1-4e84-bdb2-8aff4b03fb24)
- [WARNING_LETTER - 2025-03-25](https://www.keypedia.com/records/warning_letter/creative-essences-inc/31117288-acdc-4260-a1ca-8e478e0a0da8)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/aranjeet-singh/7359f43e-0e36-4cdd-a77d-3371d8b44b99)
- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Thuy Tram L. Nguyen](https://www.keypedia.com/people/thuy-tram-l-nguyen/b58f2445-728e-4f79-b7eb-4dfb7e982e25)

Company: https://www.keypedia.com/companies/creative-essences-inc/ad4207ce-5720-4c6b-ad8b-7b67087bd0d9

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b