FDA Inspection 1270045 — Evaric Pharmaceuticals Inc.
The FDA completed an inspection of Evaric Pharmaceuticals Inc. on May 16, 2025 in Hauppauge, NY. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 16, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |