Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Dec 2011
21 CFR 600.14(a)(1)
Who must report - manufacturer
Cited by Susan M Jackson, Helen B Ricalde
2 Dec 2011
21 CFR 820.40
Lack of procedures, or not maintained
Cited by Susan M Jackson, Helen B Ricalde
2 Dec 2011
21 CFR 820.70(b)
Production and process changes - failure to follow procedure
Cited by Susan M Jackson, Helen B Ricalde
2 Dec 2011
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Susan M Jackson, Helen B Ricalde
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 600.14(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | 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(b) | 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(b) | 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 8 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