817363
OLAAX Corp. — FEI 3005602667
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 4, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Bartow, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 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 |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |