FDA Inspection 1201911 — Beauty & Spa Concepts, DBA Beenefits
The FDA completed an inspection of Beauty & Spa Concepts, DBA Beenefits on April 5, 2023 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 22 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 5, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15571 | 21 CFR 111.153 | Written procedures - packaging |
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15621 | 21 CFR 111.180(b)(1) | Written procedures - rejected components, packaging, labels |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |