FDA Inspection 574066 — DeLaval Direct Distribution, A Division Of DeLaval, Inc.
The FDA completed an inspection of DeLaval Direct Distribution, A Division Of DeLaval, Inc. on Apr 10, 2009 in Plymouth, IN. 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). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 10, 2009
- Fiscal Year
- 2009
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Plymouth, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |