Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-20.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jun 2025 – 20 Jun 2025 | Biologics | Clean | |
| 6 Jul 2015 – 9 Jul 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Nov 2011 | Not recorded | Clean | |
| 16 Sep 2010 | Not recorded | Clean | |
| 23 Apr 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Jul 2015
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Lauren E Skokan Priest, Lauren E Skokan
9 Jul 2015
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Lauren E Skokan Priest, Lauren E Skokan
9 Jul 2015
21 CFR 820.70(i)
Software validation for automated processes
Cited by Lauren E Skokan Priest, Lauren E Skokan
9 Jul 2015
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Lauren E Skokan Priest, Lauren E Skokan
9 Jul 2015
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Lauren E Skokan Priest, Lauren E Skokan
Investigators
FDA investigators tied to this site in the record.
Creighton T Tuzon1 insp.
Lauren E Skokan Priest1 insp.
Lauren E Skokan1 insp.
Nancy L Neiger1 insp.
Phillip M Pontikos1 insp.
Deborah M Trout1 insp.
Kimberly Lewandowski-Walker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind bioLytical Laboratories, Inc.'s 2 Form 483s
Source PDFs 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