FDA Inspection 755078 — Lonza Walkersville, Inc.
The FDA completed an inspection of Lonza Walkersville, Inc. on December 2, 2011 in Walkersville, MD. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Walkersville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3142 | 21 CFR 820.150(a) | Storage procedures to avoid release of unsuitable product |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 537 | 21 CFR 820.70(a) | Production processes |
| 540 | 21 CFR 820.70(b) | Production and process changes - failure to follow procedure |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |