FDA Inspection 1143847 — EXACT SCIENTIFIC SERVICES, INC.
The FDA completed an inspection of EXACT SCIENTIFIC SERVICES, INC. on June 3, 2021 in Ferndale, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 3, 2021
- Fiscal Year
- 2021
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Ferndale, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |