Overview
- 11 public-safe observations are available for this inspection.
- 11 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.
7 Sep 2012
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Jose A Cruz Gonzalez, Ivis L Negron Torres
7 Sep 2012
21 CFR 211.28(a)
Protective Apparel Not Worn
Cited by Jose A Cruz Gonzalez, Ivis L Negron Torres
7 Sep 2012
21 CFR 211.56(b)
Written sanitation procedures not followed
Cited by Jose A Cruz Gonzalez, Ivis L Negron Torres
7 Sep 2012
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Jose A Cruz Gonzalez, Ivis L Negron Torres
7 Sep 2012
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jose A Cruz Gonzalez, Ivis L Negron Torres
Inspected site
GPGland Pharma LimitedHyderabad, India
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | 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) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 observations
Every observation in full, 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