FDA Inspection 971693 — Michael Zakany LLC
The FDA completed an inspection of Michael Zakany LLC on April 19, 2016 in Zanesville, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 19, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food and Color Additives Petition Review
- Location
- Zanesville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1556 | 21 CFR 110.35(b)(2) | Storage requirements |
| 1562 | 21 CFR 110.35(d) | Failure to clean - general |
| 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 |
| 3089 | 21 CFR 114.100(c) | Process deviations- identification and records |
| 3645 | 21 CFR 110.10(d) | Supervision |
| 3654 | 21 CFR 110.37(d)(1) | Maintained |
| 4475 | 21 CFR 108.25(c)(3)(i) | Process adherence |
| 985 | 21 CFR 110.10(b)(1) | Suitable outer garments |
| 990 | 21 CFR 110.10(b)(3) | Not washed/sanitized when appropriate |