Overview
- 10 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 Feb 2017
21 CFR 807.21(b)
Listing not updated
Cited by James M Simpson, Steven P Donald, Marc S Neubauer
6 Feb 2017
21 CFR 820.20(b)
Lack of or inadequate organizational structure
Cited by James M Simpson, Steven P Donald, Marc S Neubauer
6 Feb 2017
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by James M Simpson, Steven P Donald, Marc S Neubauer
6 Feb 2017
21 CFR 820.140
Lack of or inadequate procedures for handling
Cited by James M Simpson, Steven P Donald, Marc S Neubauer
6 Feb 2017
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by James M Simpson, Steven P Donald, Marc S Neubauer
Inspected site
LWLonza Walkersville, Inc.Walkersville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 807.21(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.140 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 10 observations
The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere