710553
FB Laboratories Inc. — FEI 3004341605
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 9, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 15462 | 21 CFR 111.20(d)(1)(iv) | Physical plant - temperature, humidity controls |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15571 | 21 CFR 111.153 | Written procedures - packaging |
| 15582 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15679 | 21 CFR 111.315(b)(1) | Laboratory control processes - sampling plans; packaging |
| 15687 | 21 CFR 111.315(b)(4) | Sampling plans; product for packaging, labeling |
| 15689 | 21 CFR 111.315(b)(3) | Sampling plans; finished batches |
| 15693 | 21 CFR 111.315(b)(1) | Laboratory control processes - sampling plans; labeling |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15778 | 21 CFR 111.415(b) | Dietary supplement - protect, contamination |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15883 | 21 CFR 111.75(i) | Corrective action plan |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 15995 | 21 CFR 111.127(d) | Quality control operations - packaged, labeled; specifications |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |