Overview
- 10 public-safe observations are available for this inspection.
- 2 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.
10 Mar 2017
21 CFR 111.255(b)
Batch record - complete
Cited by Constantin Y Philopoulos, Charles L Zhou
10 Mar 2017
21 CFR 111.255(b)
Batch record - complete
Cited by Constantin Y Philopoulos, Charles L Zhou
10 Mar 2017
21 CFR 111.255(b)
Batch record - complete
Cited by Constantin Y Philopoulos, Charles L Zhou
10 Mar 2017
21 CFR 111.255(b)
Batch record - complete
Cited by Constantin Y Philopoulos, Charles L Zhou
10 Mar 2017
21 CFR 211.198(b)(2)
Complaint Investigation/Follow-Up Findings
Cited by Constantin Y Philopoulos, Charles L Zhou
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(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 5x |
Full 483 report
Get the verbatim text of all 10 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