Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
24 Jun 2013
21 CFR 1271.55(a)(2)
Eligibility statement--basis of determination
Cited by Denise M Visco, Jonee J Mearns
24 Jun 2013
21 CFR 1271.55(a)(3)
Summary--records used to make determination
Cited by Denise M Visco, Jonee J Mearns
24 Jun 2013
21 CFR 1271.65(a)
Improper release prevention--storage, I.D.
Cited by Denise M Visco, Jonee J Mearns
Inspected site
RCReproductive Center Of Central New JerseyS Plainfield, United States
Inspection team
DMDenise M Visco
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.55(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.65(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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