# FDA 483 - Creative Essences Inc - September 04, 2020

Source: https://www.keypedia.com/records/483/creative-essences-inc/553361d2-5ee1-4e84-bdb2-8aff4b03fb24

> FDA 483 for Creative Essences Inc on September 04, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Creative Essences Inc
- Inspection Date: 2020-09-04
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Creative Essences Inc, an OTC drug product manufacturer in Santa Fe Springs, CA, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight a systemic lack of adequate procedures and documentation across critical areas including employee training, complaint handling, investigations, equipment maintenance, facility repair, process validation, batch records, laboratory controls, stability testing, raw material management, and labeling controls. These issues indicate a severe lack of adherence to cGMP requirements, potentially impacting drug product quality, safety, and purity.

## Related Documents

- [483 - 2025-03-25](https://www.keypedia.com/records/483/creative-essences-inc/733e3cfd-7f1c-43a6-bdd7-d3ccfa7ecc66)
- [WARNING_LETTER - 2025-03-25](https://www.keypedia.com/records/warning_letter/creative-essences-inc/31117288-acdc-4260-a1ca-8e478e0a0da8)

## Related Officers

- [Stephanie A. Slater](https://www.keypedia.com/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6