FDA Inspection 783912 — Cre 8 It, Inc.
The FDA completed an inspection of Cre 8 It, Inc. on Jun 4, 2012 in Minneapolis, MN. 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). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 4, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12733 | 21 CFR 120.11(a)(1)(iv)(C) | Calibration, testing - record review timeliness |
| 12742 | 21 CFR 120.8(a) | HACCP plan not implemented |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 15302 | 21 CFR 120.11(a)(2) | Calibration, testing - no records |
| 6010 | 21 CFR 123.8(a)(3)(i) | Monitoring record review adequacy |
| 6020 | 21 CFR 123.9(a) | Records - content |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |
| 9928 | 21 CFR 120.12(b) | Records - general - include name, date, time |
| 9947 | 21 CFR 120.11(b) | HACCP plan - not validated |
| 9965 | 21 CFR 120.25(b) | Process verification - sampling each product |
| 9969 | 21 CFR 120.25(a) | Process verification - sample size |
| 9981 | 21 CFR 120.12(b)(4) | Records - actual values |