FDA Inspection 675800 — Nutritional Counselors Of America
The FDA completed an inspection of Nutritional Counselors Of America on August 12, 2010 in Spencer, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 22 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 12, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Spencer, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15389 | 21 CFR 111.10(b)(1) | Outer garments |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15403 | 21 CFR 111.12(b) | Personnel - quality control operations; responsibilities |
| 15456 | 21 CFR 111.20(b) | Physical plant - space; equipment, materials |
| 15461 | 21 CFR 111.20(d)(1)(iii) | Physical plant - ventilation, environmental control |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15571 | 21 CFR 111.153 | Written procedures - packaging |
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15579 | 21 CFR 111.155(c)(1) | Components - representative samples |
| 15623 | 21 CFR 111.180(b)(2) | Records - receiving; components, packaging, labels, products |
| 15728 | 21 CFR 111.365(d) | Chemical, microbiological, other test-contaminated components |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15883 | 21 CFR 111.75(i) | Corrective action plan |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |