Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
6 Jun 2022
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Ivan E Reyes, Samantha J Pinizzotto
6 Jun 2022
21 CFR 1271.55(b)(2)
Listing and interpretation of CD tests performed
Cited by Ivan E Reyes, Samantha J Pinizzotto
6 Jun 2022
21 CFR 1271.55(b)(4)
Reasons for ineligibility on summary
Cited by Ivan E Reyes, Samantha J Pinizzotto
6 Jun 2022
21 CFR 1271.55(d)(1)(iii)
Documentation--determination, by whom, date
Cited by Ivan E Reyes, Samantha J Pinizzotto
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 | 1x |
| 21 CFR 1271.50(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(d)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.65(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 7 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