# FDA 483 - Chemcor Chemical Corp - August 31, 2022

Source: https://www.keypedia.com/records/483/chemcor-chemical-corp/340eaf3a-6ae1-45b0-aeb7-3389ac675576

> FDA 483 for Chemcor Chemical Corp on August 31, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Chemcor Chemical Corp
- Inspection Date: 2022-08-31
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Chemcor Chemical Corp in Chino, CA, a manufacturer of OTC drug products, revealed significant deficiencies across its manufacturing operations. The firm lacked adequate written procedures for production and process controls, including validations and equipment qualification, and failed to establish a functional quality control unit. Additionally, laboratory controls were insufficient, and components were not handled or stored to prevent contamination.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)
- [Claudia M. Perez-Kasmarski](https://www.keypedia.com/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

Company: https://www.keypedia.com/companies/chemcor-chemical-corp/70375426-04f1-470e-979b-b07360a26603

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