FDA Inspection 837295 — David C. Kauffman
The FDA completed an inspection of David C. Kauffman on June 21, 2013 in Kalona, IA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 21, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Kalona, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 16118 | 21 CFR 118.4 | Written SE plan not implemented/followed |
| 16120 | 21 CFR 118.4 | Written SE plan lacks required elements |
| 16122 | 21 CFR 118.4(a)(2)(i) | Pullet environment testing |
| 16133 | 21 CFR 118.4(b)(2) | Cross contamination from equipment |
| 16135 | 21 CFR 118.4(b)(4) | Stray animals |
| 16184 | 21 CFR 118.9 | Lack of supervisory personnel |
| 16191 | 21 CFR 118.10(a)(2) | Pullets records documentation |
| 16195 | 21 CFR 118.10(a)(3)(iv) | Refrigeration requirements documentation |
| 16203 | 21 CFR 118.10(b)(1) | Name and location |
| 16204 | 21 CFR 118.10(b)(2) | Date and time of activity |
| 16206 | 21 CFR 118.10(b)(3) | Signature and date on SE plans |