FDA Inspection 1064056 — NutriResearch Inc
The FDA completed an inspection of NutriResearch Inc on August 24, 2018 in Kent, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 24, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Kent, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15777 | 21 CFR 111.415(c) | Filling, assembling, packaging, labeling - sanitary handling |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |