646568
AFAM Concept, Inc. — FEI 3003818194
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 12, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2021 | 21 CFR 211.188(b)(9) | Container/Closure Description |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 4327 | 21 CFR 211.122(c) | Records fail to include |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4376 | 21 CFR 211.188(b)(4) | Weights and measures of components used |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |