Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
27 Oct 2016
21 CFR 211.110(a)
Control procedures fail to include the following
Cited by Albert C Cheng, Marcus F Yambot, Sundy V Sedwick, Terrance P Nguyen, Sundy Ven
27 Oct 2016
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Albert C Cheng, Marcus F Yambot, Sundy V Sedwick, Terrance P Nguyen, Sundy Ven
27 Oct 2016
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Albert C Cheng, Marcus F Yambot, Sundy V Sedwick, Terrance P Nguyen, Sundy Ven
27 Oct 2016
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Albert C Cheng, Marcus F Yambot, Sundy V Sedwick, Terrance P Nguyen, Sundy Ven
27 Oct 2016
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Albert C Cheng, Marcus F Yambot, Sundy V Sedwick, Terrance P Nguyen, Sundy Ven
Inspected site
HCHyland's Consumer Health Inc.Los Angeles, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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