FDA Inspection 1070156 — Sparhawk Laboratories, Inc.
The FDA completed an inspection of Sparhawk Laboratories, Inc. on October 29, 2018 in Lenexa, KS. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 29, 2018
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Lenexa, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |