FDA Inspection 1288942 — Pelame, LLC D.B.A. Nanoceutical Solutions
The FDA completed an inspection of Pelame, LLC D.B.A. Nanoceutical Solutions on Jun 25, 2026 in Boerne, TX. 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). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 25, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Boerne, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 22819 | 21 CFR 111.12 | Personnel - qualifications |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22853 | 21 CFR 111.80(a) | Components packaging, labels used |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22907 | 21 CFR 111.475(b) | Records - written procedures holding and distribution; product distribution |