Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
30 Mar 2026
21 CFR 111.123(b)(3)
Quality control - batch released, adulteration
Cited by James R Birkenstamm, Dhaval H Patel
30 Mar 2026
21 CFR 111.205(b)(2)
Master manufacturing record - controls, procedures
Cited by James R Birkenstamm, Dhaval H Patel
30 Mar 2026
21 CFR 111.20(c)
Physical plant - proper precautions to prevent mix-ups, contamination
Cited by James R Birkenstamm, Dhaval H Patel
30 Mar 2026
21 CFR 111.35(b)
Make and keep records - equipment and utensils
Cited by James R Birkenstamm, Dhaval H Patel
30 Mar 2026
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by James R Birkenstamm, Dhaval H Patel
Inspected site
ZPZivaQ Pharmaceuticals Inc.East Brunswick, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.123(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b) | 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 111.83(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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