FDA Inspection 972202 — Xcel Sports Nutrition
The FDA completed an inspection of Xcel Sports Nutrition on May 27, 2016 in Lubbock, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 27, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lubbock, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15649 | 21 CFR 111.465(a)(1) | Hold - reserve samples; ordinary storage |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15783 | 21 CFR 111.410(d) | Manufacturing history |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |