FDA Inspection 546535 — D.N.A. LAB INC.
The FDA completed an inspection of D.N.A. LAB INC. on October 31, 2008 in Chelan, WA. 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: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 31, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chelan, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4341 | 21 CFR 211.142(a) | Quarantine - written procedures |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |