FDA Inspection 825446 — Libi Labs, Inc.
The FDA completed an inspection of Libi Labs, Inc. on Apr 1, 2013 in Largo, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Apr 1, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 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 |
| 15868 | 21 CFR 111.75(b)(2) | Specifications met - deviation, unanticipated occurrence |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |