Overview
- 9 public-safe observations are available for this inspection.
- 8 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.
23 Apr 2014
21 CFR 111.12(c)
Personnel - education, training, experience
Cited by Ileana Barreto-Pettit, Stacey F Rivette
23 Apr 2014
21 CFR 111.25(c)
Procedures - equipment - cleaning, sanitizing
Cited by Ileana Barreto-Pettit, Stacey F Rivette
23 Apr 2014
21 CFR 111.320(a)
Examination, testing; appropriate
Cited by Ileana Barreto-Pettit, Stacey F Rivette
23 Apr 2014
21 CFR 111.365(a)
Conditions, controls -protect; microorganisms, contamination
Cited by Ileana Barreto-Pettit, Stacey F Rivette
23 Apr 2014
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Ileana Barreto-Pettit, Stacey F Rivette
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 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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