FDA Inspection 710788 — JSP Enterprises, LTD
The FDA completed an inspection of JSP Enterprises, LTD on February 11, 2011 in Denver, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 25 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 11, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1006 | 21 CFR 110.10(b)(8) | Personal food/drink/tobacco |
| 1060 | 21 CFR 123.11(a) | SSOP(S) |
| 1128 | 21 CFR 110.40(a) | Installation and maintenance of equipment (S) |
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1405 | 21 CFR 110.10(b)(6) | Failure to wear |
| 1429 | 21 CFR 110.20(b)(6) | Fans/air blowing equipment |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1562 | 21 CFR 110.35(d) | Failure to clean - general |
| 1570 | 21 CFR 110.35(d)(5) | Safe and adequate for use |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 1698 | 21 CFR 110.80(b)(5) | Work-in-progress |
| 1701 | 21 CFR 110.80(b)(7) | Equipment, containers, utensils |
| 3643 | 21 CFR 110.10(b)(5) | Glove condition |
| 3661 | 21 CFR 110.37(e)(5) | Signs |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 6010 | 21 CFR 123.8(a)(3)(i) | Monitoring record review adequacy |
| 6020 | 21 CFR 123.9(a) | Records - content |
| 904 | 21 CFR 123.6(b) | No HACCP plan |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 933 | 21 CFR 123.8(a)(2)(ii) | Calibration - adequacy |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |
| 985 | 21 CFR 110.10(b)(1) | Suitable outer garments |
| 990 | 21 CFR 110.10(b)(3) | Not washed/sanitized when appropriate |