Overview
- 11 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-25.
At a glance
Inspections
11
Form 483s
2
EIRs
6
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2025 – 25 Nov 2025 | Biologics | Clean | |
| 4 Feb 2025 – 7 Feb 2025 | Human Drugs | Clean | |
| 28 Aug 2023 – 1 Sep 2023 | Biologics | 483 | On file |
| 14 Jan 2020 – 22 Jan 2020 | Human Drugs | Clean | |
| 13 Apr 2015 – 17 Apr 2015 | Human Drugs | 483 | View 483 → |
| 11 Sep 2013 – 12 Sep 2013 | Biologics | Clean | |
| 24 Aug 2012 | Not recorded | Clean | |
| 6 Jan 2010 | Not recorded | Clean | |
| 16 Jul 2008 | Not recorded | Clean | |
| 3 Jun 2004 | Not recorded | Clean | |
| 27 Dec 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Apr 2015
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Anastasia M Shields, Ko U Min, Gayle S Lawson
17 Apr 2015
21 CFR 211.194(a)
Complete test data included in records
Cited by Anastasia M Shields, Ko U Min, Gayle S Lawson
17 Apr 2015
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Anastasia M Shields, Ko U Min, Gayle S Lawson
Investigators
FDA investigators tied to this site in the record.
Anastasia M Shields2 insp.
Priscilla M Pastrana1 insp.
Hector A Carrero1 insp.
Grace I Cortesini1 insp.
Russell J Glapion1 insp.
Craig D Zagata1 insp.
Ko U Min1 insp.
Gayle S Lawson1 insp.
Michele M Falchek1 insp.
Julianne C Mccullough1 insp.
Anita R Michael1 insp.
Vlada Matusovsky1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Advanced Therapies LLC'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