884193
Enterprise Mac, LLC — FEI 3010804175
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 16, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15535 | 21 CFR 111.255(d) | Batch record - 1 year, 2 years |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 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 |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15891 | 21 CFR 111.80(a) | Components packaging, labels received |
| 16014 | 21 CFR 111.140(b)(1) | QC ops; written procedures; material review, disposition |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |