FDA Inspection 719771 — Nutritional Counselors Of America
The FDA completed an inspection of Nutritional Counselors Of America on April 12, 2011 in Spencer, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 23 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 12, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Spencer, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15389 | 21 CFR 111.10(b)(1) | Outer garments |
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15461 | 21 CFR 111.20(d)(1)(iii) | Physical plant - ventilation, environmental control |
| 15463 | 21 CFR 111.20(d)(1)(v) | Physical plant - aisles, working spaces |
| 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 |
| 15563 | 21 CFR 111.260(l)(1)(i) | Batch record - quality control review; monitoring |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15614 | 21 CFR 111.170 | Quarantine component, package, labels, rejected product |
| 15623 | 21 CFR 111.180(b)(2) | Records - receiving; components, packaging, labels, products |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15722 | 21 CFR 111.365(j) | Containers - segregating, identifying |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15775 | 21 CFR 111.415(e) | Dietary supplement containers - mix-ups |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16007 | 21 CFR 111.135 | Quality control operations - product complaints |