Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
27 Jul 2009
21 CFR 1271.50(a)
Responsible person to determine, document
Cited by Sherri J Jackson, Catherine V Quinlan
27 Jul 2009
21 CFR 1271.50(b)(2)
Donor testing not negative for CD agents
Cited by Sherri J Jackson, Catherine V Quinlan
27 Jul 2009
21 CFR 1271.55(d)(2)
Accurate, indelible, legible
Cited by Sherri J Jackson, Catherine V Quinlan
27 Jul 2009
21 CFR 1271.60(a)
Completion of eligibility determination
Cited by Sherri J Jackson, Catherine V Quinlan
27 Jul 2009
21 CFR 1271.80(d)(1)
Reactive tests--not determined ineligible
Cited by Sherri J Jackson, Catherine V Quinlan
Inspected site
RMReproductive Medicine Associates of Michigan, PLCTroy, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.50(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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