Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
5 Sep 2025
21 CFR 117.135(a)(1)
Process preventive controls - Implement
Cited by Desiree C Iya, Kawshalya Pathiraja, Natalie Rodriguez, Ashley S Ertzman, Yuanjie Liu
5 Sep 2025
21 CFR 117.135(c)(3)
Sanitation preventive controls - Appropriate (Adequate)
Cited by Desiree C Iya, Kawshalya Pathiraja, Natalie Rodriguez, Ashley S Ertzman, Yuanjie Liu
5 Sep 2025
21 CFR 117.165(a)(4)
Process preventive controls - Record review
Cited by Desiree C Iya, Kawshalya Pathiraja, Natalie Rodriguez, Ashley S Ertzman, Yuanjie Liu
5 Sep 2025
21 CFR 117.190(a)
Sanitation preventive controls - Implementation records
Cited by Desiree C Iya, Kawshalya Pathiraja, Natalie Rodriguez, Ashley S Ertzman, Yuanjie Liu
Inspected site
PBProlacta Bioscience IncCity Of Industry, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.165(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.190(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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