Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-06.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Mar 2025 – 6 Mar 2025 | Biologics | Clean | |
| 25 Jul 2023 – 26 Jul 2023 | Biologics | Clean | |
| 8 Jul 2019 – 11 Jul 2019 | Biologics | 483 | View 483 → |
| 10 Apr 2017 – 17 Apr 2017 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jul 2019
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Shavon L Square
17 Apr 2017
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by La-Tasha M Gunter
17 Apr 2017
21 CFR 606.100(b)(15)
Schedules and procedures for equipment & calibration
Cited by La-Tasha M Gunter
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(b)(15) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(f)(6)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.21(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind NIH Donor Center at Fishers Lane's 2 Form 483s
Source PDFs, 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