848304
FOCUS Laboratories, Inc. — FEI 3008990081
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 13, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- North Little Rock, AR (United States)
Citations
| ID | CFR | Description |
|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15820 | 21 CFR 111.55 | Production, process controls - packaged, labeled |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15902 | 21 CFR 111.83(b)(4) | Reserve sample - twice the quantity |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15940 | 21 CFR 111.105(h) | Quality control - production, process control |
| 4356 | 21 CFR 211.166(b) | Tentative expiration date |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |
| 8935 | FDCA 760(b)(1) | Failure of responsible person to report AE (non-RX Drug) |