FDA Inspection 548319 — Lonza Walkersville, Inc.
The FDA completed an inspection of Lonza Walkersville, Inc. on Oct 10, 2008 in Walkersville, MD. 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). 10 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 10, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Walkersville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 3159 | 21 CFR 820.184 | DHR content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3453 | 21 CFR 601.12(c) | Moderate changes to an approved application |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |