Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-18.
At a glance
Inspections
11
Form 483s
6
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jun 2025 – 18 Jun 2025 | Human Drugs | 483 | On file |
| 27 Feb 2024 – 8 Mar 2024 | Human Drugs | 483 | On file |
| 1 Feb 2024 – 6 Feb 2024 | Human Drugs | Clean | |
| 14 Nov 2017 – 15 Mar 2018 | Human Drugs | 483 | On file |
| 6 Jun 2016 – 11 Jul 2016 | Human Drugs | 483 | On file |
| 6 May 2016 – 25 May 2016 | Human Drugs | Clean | |
| 23 Oct 2013 – 5 Dec 2013 | Human Drugs | 483 | On file |
| 15 Jan 2013 | Not recorded | Clean | |
| 20 Oct 2011 | Not recorded | Clean | |
| 18 Jul 2011 | Not recorded | 483 | On file |
| 16 Jul 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Mar 2018
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Norman K Starks, Nicholas P Diorio
11 Jul 2016
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Christopher D Leach, Marie B Buen-Bigornia
11 Jul 2016
21 CFR 211.67(b)(5)
Cleaning SOPs/equipment protection
Cited by Christopher D Leach, Marie B Buen-Bigornia
11 Jul 2016
21 CFR 211.80(a)
Procedures To Be in Writing
Cited by Christopher D Leach, Marie B Buen-Bigornia
11 Jul 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Christopher D Leach, Marie B Buen-Bigornia
Investigators
FDA investigators tied to this site in the record.
Nibin Varghese2 insp.
Tyler M Peterson2 insp.
Debra I Love2 insp.
Ramia Brzenjy1 insp.
Supreet K Sran1 insp.
Gabriel Bermudez-Picart1 insp.
Yuanyuan Li1 insp.
Norman K Starks1 insp.
Nicholas P Diorio1 insp.
Christopher D Leach1 insp.
Marie B Buen-Bigornia1 insp.
Bryan L Mcguckin1 insp.
Michele L Glendenning1 insp.
Russell K Riley1 insp.
Kathleen S Tormey1 insp.
Marcia A Worley1 insp.
Bruce H Mccullough1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Xttrium Laboratories, Inc.'s 6 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