Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Apr 2026
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Robert J Ham, Logan T Williams, Paranthaman SenthamaraiKannan, Supreet K Sran
2 Apr 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Robert J Ham, Logan T Williams, Paranthaman SenthamaraiKannan, Supreet K Sran
2 Apr 2026
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Robert J Ham, Logan T Williams, Paranthaman SenthamaraiKannan, Supreet K Sran
2 Apr 2026
21 CFR 211.165(d)
Acceptance/Rejection Levels
Cited by Robert J Ham, Logan T Williams, Paranthaman SenthamaraiKannan, Supreet K Sran
2 Apr 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Robert J Ham, Logan T Williams, Paranthaman SenthamaraiKannan, Supreet K Sran
Inspected site
BHBaxter Healthcare CorporationRound Lake, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 observations
The full inspection record, as Atlas holds it, 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