FDA Inspection 600251 — MEK Salsaco LLC dba La Estrellita
The FDA completed an inspection of MEK Salsaco LLC dba La Estrellita on August 5, 2009 in Brighton, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 21 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Brighton, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1007 | 21 CFR 110.10(b)(9) | Precautions against contamination--micro, foreign substances |
| 1126 | 21 CFR 110.40(a) | Precluding contaminants |
| 1128 | 21 CFR 110.40(a) | Installation and maintenance of equipment (S) |
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 12720 | 21 CFR 1.225 | Not registered |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1763 | 21 CFR 110.35(b)(1) | Safe and adequate for use |
| 3062 | 21 CFR 114.10 | Personnel |
| 3067 | 21 CFR 114.80(a) | Quality control procedures |
| 3072 | 21 CFR 114.80(a)(1) | Thermal processing |
| 3073 | 21 CFR 114.80(a)(2) | pH testing |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 3085 | 21 CFR 114.100(a) | Raw materials, packaging, finished product |
| 3086 | 21 CFR 114.100(b) | Maintenance of processing and production records |
| 3088 | 21 CFR 114.100(b) | Processing and production - required information |
| 3090 | 21 CFR 114.100(d) | Product distribution |
| 3661 | 21 CFR 110.37(e)(5) | Signs |
| 3662 | 21 CFR 110.37(e)(6) | Refuse receptacles |
| 4419 | 21 CFR 110.10(c) | Level of competency (S) |
| 990 | 21 CFR 110.10(b)(3) | Not washed/sanitized when appropriate |