FDA Inspection 811453 — Dairy Manufacturers, Inc
The FDA completed an inspection of Dairy Manufacturers, Inc on December 19, 2012 in Prosper, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 19, 2012
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Prosper, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1360 | FDCA 501(a)(5) | Expired drugs administered |
| 1638 | 21 CFR 225.42(b)(5) | Elements of receipt record |
| 1811 | 21 CFR 225.58(b)(1) | Three assays per year |
| 1850 | 21 CFR 225.58(d) | Assay results out of specification |
| 2074 | 21 CFR 225.102(a) | Lack of Master Record File |
| 2076 | 21 CFR 225.102(b)(1) | Elements of the Master Record File |
| 2093 | 21 CFR 225.102(b)(2) | Elements of production record(s) |
| 4542 | 21 CFR 225.102(a) | Lack of Production Record(s) |