# FDA 483 - CASAD Company Inc - October 08, 2025

Source: https://www.keypedia.com/records/483/casad-company-inc/fa1046ea-1c49-4489-8c86-119c85029638

> FDA 483 for CASAD Company Inc on October 08, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CASAD Company Inc
- Inspection Date: 2025-10-08
- Product Type: drugs
- Summary: CASAD Company Inc., a drug relabeler located in Coldwater, OH, underwent an FDA inspection from October 7-8, 2025. The inspection resulted in a Form FDA 483, detailing significant observations related to the company's quality systems and record-keeping practices. The primary issues centered on a deficient Quality Control Unit, a repeat observation from a previous inspection. Specifically, CASAD Company Inc. lacked written procedures for managing deviations, corrective and preventive actions, and investigations. Deviations occurring during drug relabeling were not documented, and the Quality Department failed to review, reject, or approve relabeled drug products for distribution. Furthermore, there were no quality agreements in place with contract manufacturers, leaving roles and responsibilities undefined. A second critical observation noted the absence of batch production and control records for relabeled drug products. The firm reportedly released numerous batches of two different drug products without maintaining corresponding production records since January 2023 and November 2024, respectively. These observations indicate non-compliance with current good manufacturing practices (cGMP) for drug products, enforced under the Federal Food, Drug, and Cosmetic Act. CASAD Company Inc. is required to respond to the FDA with a plan to promptly address these deficiencies and implement robust corrective actions to ensure full regulatory compliance.

## Related Documents

- [483 - 2021-08-18](https://www.keypedia.com/records/483/casad-company-inc/dda9bbc2-5ea5-42bf-aa96-f668f71fa7d1)
- [483 - 2025-10-08](https://www.keypedia.com/records/483/casad-company-inc/4dbeb013-bed7-4bdb-939c-cd36c11ffd1d)

## Related Officers

- [Anna M. Spiros](https://www.keypedia.com/people/anna-m-spiros/13e6a69c-d3d5-431c-9895-0df9b86691b7)

Company: https://www.keypedia.com/companies/casad-company-inc/fd00bfe0-54ae-48ee-9552-228b1beb52d5