Overview
- 12 public-safe observations are available for this inspection.
- 11 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.
16 Jul 2009
21 CFR 211.110(a)
Written in-process control procedures
Cited by Omotunde O Osunsanmi, Christian Lynch
16 Jul 2009
21 CFR 820.40
Lack of procedures, or not maintained
Cited by Omotunde O Osunsanmi, Christian Lynch
16 Jul 2009
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Omotunde O Osunsanmi, Christian Lynch
16 Jul 2009
21 CFR 820.70(b)
Production and Process Change Procedures, lack of or Inad.
Cited by Omotunde O Osunsanmi, Christian Lynch
Inspected site
HIHologic, Inc.San Diego, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 12 observations
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