FDA Inspection 1304588 — CoreRX Inc.
The FDA completed an inspection of CoreRX Inc. on Feb 26, 2026 in Clearwater, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 26, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Clearwater, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |