Overview
- 11 public-safe observations are available for this inspection.
- 10 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.
27 Feb 2009
21 CFR 211.25(a)
GMP Training Frequency
Cited by Ivis L Negron Torres, Milva E Melendez, Rebecca Parrilla
27 Feb 2009
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Ivis L Negron Torres, Milva E Melendez, Rebecca Parrilla
27 Feb 2009
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Ivis L Negron Torres, Milva E Melendez, Rebecca Parrilla
27 Feb 2009
21 CFR 211.84(b)
Representative Samples
Cited by Ivis L Negron Torres, Milva E Melendez, Rebecca Parrilla
27 Feb 2009
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Ivis L Negron Torres, Milva E Melendez, Rebecca Parrilla
Inspected site
APAuro PR Inc.Caguas, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | 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