FDA Inspection 1068303 — Columbia Nutritional LLC
The FDA completed an inspection of Columbia Nutritional LLC on Oct 4, 2018 in Lewis Center, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 4, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lewis Center, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15506 | 21 CFR 111.27(a)(4) | Equipment - bonded seams |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |