Overview
- 5 public-safe observations are available for this inspection.
- 4 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.
27 Jun 2019
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Lauren N Howard, Michael P Sheehan
27 Jun 2019
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Lauren N Howard, Michael P Sheehan
27 Jun 2019
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Lauren N Howard, Michael P Sheehan
27 Jun 2019
21 CFR 211.192
Written record of investigation incomplete
Cited by Lauren N Howard, Michael P Sheehan
27 Jun 2019
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Lauren N Howard, Michael P Sheehan
Inspected site
HIHyalynx IncMadisonville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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