Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
4 Jun 2014
21 CFR 111.35(b)(6)
Documentation - equipment functions; intended use
Cited by Kelley L Clark, Constantin Y Philopoulos
4 Jun 2014
21 CFR 111.60(a)
Production, in- process control system design, master record
Cited by Kelley L Clark, Constantin Y Philopoulos
4 Jun 2014
21 CFR 111.65
Quality control - packaged, labeled
Cited by Kelley L Clark, Constantin Y Philopoulos
4 Jun 2014
21 CFR 111.255(a)
Batch record - every batch
Cited by Kelley L Clark, Constantin Y Philopoulos
4 Jun 2014
21 CFR 111.410(b)
Label, packaging - discrepancies
Cited by Kelley L Clark, Constantin Y Philopoulos
Inspected site
HLHello Life, IncGrand Rapids, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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