Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-17.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Mar 2023 – 17 May 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Oct 2021 – 12 Nov 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Oct 2018 – 2 Nov 2018 | Medical Devices & Rad Health | WL | View 483 → |
| 26 May 2015 – 1 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Feb 2012 | Not recorded | Clean | |
| 15 Jan 2009 | Not recorded | Clean | |
| 14 Sep 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 May 2023
21 CFR 820.150
Lack of or inadequate procedures for storage.
Cited by Nabil Nakhoul, Diane M Biron
17 May 2023
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Nabil Nakhoul, Diane M Biron
17 May 2023
21 CFR 820.70(i)
Software validation for automated processes
Cited by Nabil Nakhoul, Diane M Biron
Investigators
FDA investigators tied to this site in the record.
Diane M Biron3 insp.
Nabil Nakhoul1 insp.
Stephen C Smith1 insp.
Justine M Corson1 insp.
John A Sciacchitano1 insp.
Suzanne M Healy1 insp.
Laurie B Frazier1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind TEI Biosciences, Inc.'s 4 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