FDA Inspection 770517 — Tri State Agri Services, Llc
The FDA completed an inspection of Tri State Agri Services, Llc on March 1, 2012 in Afton, OK. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 1, 2012
- Fiscal Year
- 2012
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Afton, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1491 | 21 CFR 225.30(b)(2) | Equipment maintenance & cleanliness |
| 1539 | 21 CFR 225.42(b)(3) | Identification and storage of bulk drugs |
| 1760 | 21 CFR 225.42(b)(6) | Lot number or shipment I.D. number |
| 1811 | 21 CFR 225.58(b)(1) | Three assays per year |
| 1821 | 21 CFR 225.58(b)(1) | First batch assay |
| 1850 | 21 CFR 225.58(d) | Assay results out of specification |
| 1930 | 21 CFR 225.65(b)(3) | Sequential production |
| 1953 | 21 CFR 225.80(b)(2) | Maintaining proofread label |
| 2075 | 21 CFR 225.102(b)(1) | Preparation of Master Record File |
| 2076 | 21 CFR 225.102(b)(1) | Elements of the Master Record File |
| 2077 | 21 CFR 225.102(b)(1) | Master Record File - kept one year after production |
| 2093 | 21 CFR 225.102(b)(2) | Elements of production record(s) |
| 2097 | 21 CFR 225.102(b)(4) | Daily review of production records |
| 2233 | 21 CFR 225.115(b)(1) | Records of oral or written complaints |