FDA Inspection 839379 — NatureMost of New England, Inc.
The FDA completed an inspection of NatureMost of New England, Inc. on June 28, 2013 in Middletown, CT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 19 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 28, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Middletown, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15429 | 21 CFR 111.15(k) | Sanitation supervisors - assigned |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15581 | 21 CFR 111.155(c)(3) | Quality control - components, approve, release |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 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 |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |