FDA Inspection 891921 — Enterprise Mac, LLC
The FDA completed an inspection of Enterprise Mac, LLC on Sep 3, 2014 in Atlanta, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 3, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |