FDA Inspection 963331 — X2Zero Corporation
The FDA completed an inspection of X2Zero Corporation on March 4, 2016 in Corpus Christi, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 4, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Corpus Christi, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |