Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
9 Apr 2026
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Milton J De Jesus Tavarez, Jeffrey T Prosterman
9 Apr 2026
21 CFR 211.150
Written distribution procedure
Cited by Milton J De Jesus Tavarez, Jeffrey T Prosterman
9 Apr 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Milton J De Jesus Tavarez, Jeffrey T Prosterman
9 Apr 2026
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Milton J De Jesus Tavarez, Jeffrey T Prosterman
Inspected site
GPGlobal Packaging Systems, IncFort Worth, United States
Inspection team
JTJeffrey T Prosterman
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(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