FDA Inspection 1040228 — FRITZ INDUSTRIES INC
The FDA completed an inspection of FRITZ INDUSTRIES INC on Feb 7, 2018 in Mesquite, TX. 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). 13 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 7, 2018
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Mesquite, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1726 | 21 CFR 211.86 | Rotation of components/containers/closures |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |