FDA Inspection 818921 — McKathan Products Inc.
The FDA completed an inspection of McKathan Products Inc. on Feb 19, 2013 in Reddick, FL. 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). 10 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 19, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Reddick, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |