Overview
- 14 public-safe observations are available for this inspection.
- 14 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 May 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Laurissa S Flowers, Emily B Camire, Homero W Aguilar
1 May 2026
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Laurissa S Flowers, Emily B Camire, Homero W Aguilar
1 May 2026
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Laurissa S Flowers, Emily B Camire, Homero W Aguilar
1 May 2026
21 CFR 211.110(a)
Written in-process control procedures
Cited by Laurissa S Flowers, Emily B Camire, Homero W Aguilar
1 May 2026
21 CFR 211.115(b)
Reprocessing/quality control unit
Cited by Laurissa S Flowers, Emily B Camire, Homero W Aguilar
Inspected site
GTGVS TM, IncCovina, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 14 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