Overview
- 10 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.
10 May 2012
21 CFR 111.70(b)(3)
Specifications - contamination limits
Cited by Jennifer Lalama, Joanne E King, German Rivera
10 May 2012
21 CFR 111.70(c)(1)
Specifications - in-process contamination limits
Cited by Jennifer Lalama, Joanne E King, German Rivera
10 May 2012
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jennifer Lalama, Joanne E King, German Rivera
10 May 2012
21 CFR 211.25(a)
GMP Training Frequency
Cited by Jennifer Lalama, Joanne E King, German Rivera
10 May 2012
21 CFR 211.63
Equipment Design, Size and Location
Cited by Jennifer Lalama, Joanne E King, German Rivera
Inspected site
PAPLD Acquisitions LLC D/B/A Avema Pharma SolutionsDoral, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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