Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
23 Apr 2021
21 CFR 111.180(b)(2)
Records - receiving; components, packaging, labels, products
Cited by Joseph F Owens, Marcella D Crook, Clinton V Giustra, Rashonda N Rucker, Robert Q Green
23 Apr 2021
21 CFR 111.20(h)
Physical plant - screening against pests
Cited by Joseph F Owens, Marcella D Crook, Clinton V Giustra, Rashonda N Rucker, Robert Q Green
23 Apr 2021
21 CFR 111.453
Written procedures - holding
Cited by Joseph F Owens, Marcella D Crook, Clinton V Giustra, Rashonda N Rucker, Robert Q Green
Inspected site
HPHi-Tech Pharmaceuticals, Inc.Norcross, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.180(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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