Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2011-11-02.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Nov 2011 | Not recorded | 483 | View 483 → |
| 26 Apr 2011 | Not recorded | 483 | On file |
| 9 Feb 2010 | Not recorded | Clean | |
| 2 Apr 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Nov 2011
21 CFR 312.60
FD-1572, protocol compliance
Cited by Diane C Van Leeuwen, Lynette M Terry, Laverne Kimble
2 Nov 2011
21 CFR 312.60
Informed consent
Cited by Diane C Van Leeuwen, Lynette M Terry, Laverne Kimble
2 Nov 2011
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Diane C Van Leeuwen, Lynette M Terry, Laverne Kimble
Investigators
FDA investigators tied to this site in the record.
Diane C Van Leeuwen3 insp.
Lynette M Terry1 insp.
Laverne Kimble1 insp.
Allen F Hall1 insp.
Terrance L Thomas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.60 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pedro F. Lagrosa, M.D.'s 2 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat