FDA Inspection 914922 — Michael Zakany LLC
The FDA completed an inspection of Michael Zakany LLC on March 3, 2015 in Zanesville, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 3, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Zanesville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1128 | 21 CFR 110.40(a) | Installation and maintenance of equipment (S) |
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1402 | 21 CFR 110.10(b)(4) | Unsecured jewelry |
| 1406 | 21 CFR 110.10(b)(6) | Effective use of hair restraint |
| 16089 | FDCA 417(d)(1)(A) | Reportable food report - submission |
| 1689 | 21 CFR 110.80 | Reasonable precautions |
| 3075 | 21 CFR 114.80(a)(4) | Container testing |
| 3085 | 21 CFR 114.100(a) | Raw materials, packaging, finished product |
| 3090 | 21 CFR 114.100(d) | Product distribution |
| 3654 | 21 CFR 110.37(d)(1) | Maintained |
| 3657 | 21 CFR 110.37(d)(4) | Doors opening into processing areas |
| 3661 | 21 CFR 110.37(e)(5) | Signs |
| 4479 | 21 CFR 108.25(e) | Recall procedures |
| 990 | 21 CFR 110.10(b)(3) | Not washed/sanitized when appropriate |