FDA Inspection 582131 — LSL Healthcare Inc.
The FDA completed an inspection of LSL Healthcare Inc. on April 30, 2009 in Niles, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Niles, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3141 | 21 CFR 820.150(a) | Storage procedures to prevent mix-ups |
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3682 | 21 CFR 820.70(d) | Implementing Personnel Procedures, Health, Cleanliness. |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |