Overview
- 14 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
24 May 2018
21 CFR 1271.55(a)(2)
Eligibility statement--basis of determination
Cited by Colleen M Aspinwall
Inspected site
MSMark S. Denker, MD PABoca Raton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.50(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.55(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.55(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.55(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(d) | Cited across public-safe Form 483 observations | 2x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 14 observations
The source PDF, 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