FDA Inspection 804259 — Entrenet Nutritionals, Inc.
The FDA completed an inspection of Entrenet Nutritionals, Inc. on Nov 1, 2012 in Erie, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 1, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Erie, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15920 | 21 CFR 111.95(b)(1) | Records - established specifications |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 15988 | 21 CFR 111.123(b)(4) | Quality control supplier; product released, assurance not provided label |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |