FDA Inspection 836830 — Nutraloid Labs Inc.
The FDA completed an inspection of Nutraloid Labs Inc. on June 12, 2013 in Saugerties, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 12, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Saugerties, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15604 | 21 CFR 111.165(b) | Product received - visually examine invoice, guarantee, cert |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15783 | 21 CFR 111.410(d) | Manufacturing history |
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 15820 | 21 CFR 111.55 | Production, process controls - packaged, labeled |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 16038 | 21 CFR 111.605(b) | Records - original, true copies |
| 16047 | 21 CFR 111.510 | Returned dietary supplement - material review, disposition |