FDA Inspection 611743 — ASI Marketing Group, LLC
The FDA completed an inspection of ASI Marketing Group, LLC on September 11, 2009 in Las Vegas, NV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 11, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Las Vegas, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |