FDA Inspection 1258228 — Frontage Laboratories, Inc.
The FDA completed an inspection of Frontage Laboratories, Inc. on January 10, 2025 in Exton, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 10, 2025
- Fiscal Year
- 2025
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Exton, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |