Overview
- 14 public-safe observations are available for this inspection.
- 13 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
24 Mar 2023
21 CFR 111.105
Quality control - packaged, labeled
Cited by Joseph F Owens, Rashonda N Rucker, Crystal A Harlan, Brenda Rivera
24 Mar 2023
21 CFR 111.105(a)
Processes, specifications, written procedures
Cited by Joseph F Owens, Rashonda N Rucker, Crystal A Harlan, Brenda Rivera
24 Mar 2023
21 CFR 111.123(b)(1)
Quality control - components, identity specifications
Cited by Joseph F Owens, Rashonda N Rucker, Crystal A Harlan, Brenda Rivera
24 Mar 2023
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Joseph F Owens, Rashonda N Rucker, Crystal A Harlan, Brenda Rivera
24 Mar 2023
21 CFR 111.127(h)
QC operations - packaging, labeling; approving, rejecting
Cited by Joseph F Owens, Rashonda N Rucker, Crystal A Harlan, Brenda Rivera
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 111.303 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.127(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(B) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
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Form 483 source document
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Full 483 report
Get the verbatim text of all 14 observations
The source PDF, 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