FDA Inspection 951083 — Enterprise Mac, LLC
The FDA completed an inspection of Enterprise Mac, LLC on Nov 12, 2015 in Atlanta, GA. 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). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 12, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15973 | 21 CFR 111.120(c) | Quality control operations - material review, disposition decision |