FDA Inspection 1144633 — Pelame, LLC d.b.a. Nanoceutical Solutions
The FDA completed an inspection of Pelame, LLC d.b.a. Nanoceutical Solutions on June 24, 2021 in Boerne, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 24, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Boerne, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15428 | 21 CFR 111.15(h) | Bathrooms - clean |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15783 | 21 CFR 111.410(d) | Manufacturing history |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15890 | 21 CFR 111.80(a) | Components packaging, labels used |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |