Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-30.
At a glance
Inspections
9
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 May 2025 – 30 May 2025 | Human Drugs | 483 | View 483 → |
| 8 Dec 2021 – 10 Dec 2021 | Human Drugs | Clean | |
| 17 Jan 2019 – 23 Jan 2019 | Human Drugs | Clean | |
| 15 Feb 2018 – 23 Feb 2018 | Human Drugs | Clean | |
| 31 Oct 2016 – 4 Nov 2016 | Human Drugs | Clean | |
| 31 Jul 2014 – 1 Aug 2014 | Human Drugs | 483 | View 483 → |
| 25 Apr 2012 | Not recorded | Clean | |
| 6 May 2011 | Not recorded | Clean | |
| 18 Jun 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 May 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Joohi Castelvetere, Joseph A Piechocki, Shannon L Maisano
30 May 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Joohi Castelvetere, Joseph A Piechocki, Shannon L Maisano
30 May 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Joohi Castelvetere, Joseph A Piechocki, Shannon L Maisano
30 May 2025
21 CFR 211.63
Equipment Design, Size and Location
Cited by Joohi Castelvetere, Joseph A Piechocki, Shannon L Maisano
30 May 2025
21 CFR 211.68(b)
Computer control of master formula records
Cited by Joohi Castelvetere, Joseph A Piechocki, Shannon L Maisano
Investigators
FDA investigators tied to this site in the record.
Constantin Y Philopoulos5 insp.
Michele L Forster2 insp.
Joohi Castelvetere1 insp.
Joseph A Piechocki1 insp.
Shannon L Maisano1 insp.
Brent M Dehaan1 insp.
Charles L Zhou1 insp.
Emily J Orban1 insp.
Martha Sullivan Myrick1 insp.
Cheryl M Monroe1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Eurofins Lancaster Laboratories, Inc'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