Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Lack of or inadequate procedures
Cited by Christopher D Leach, Nicholas Z Lu, Michelle J Glembin, Clifton L Randell, Lisa T Michel
Statistical techniques - Lack of or inadequate procedures
Cited by Christopher D Leach, Nicholas Z Lu, Michelle J Glembin, Clifton L Randell, Lisa T Michel
Production processes
Cited by Christopher D Leach, Nicholas Z Lu, Michelle J Glembin, Clifton L Randell, Lisa T Michel
Environmental control Lack of or inadequate procedures
Cited by Christopher D Leach, Nicholas Z Lu, Michelle J Glembin, Clifton L Randell, Lisa T Michel
Contamination control, Lack of or inadequate procedures
Cited by Christopher D Leach, Nicholas Z Lu, Michelle J Glembin, Clifton L Randell, Lisa T Michel
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(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 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 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