FDA Inspection 719602 — Northwest Respiratory Services, LLC
The FDA completed an inspection of Northwest Respiratory Services, LLC on Apr 14, 2011 in Eagan, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 14, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Eagan, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2620 | 21 CFR 211.198(b)(2) | Complaint Record at Location of Investigation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |