Overview
- 14 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-03.
At a glance
Inspections
14
Form 483s
11
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Mar 2024 – 3 Apr 2024 | Human Drugs | 483 | View 483 → |
| 26 Apr 2021 – 7 Jun 2021 | Human Drugs | 483 | View 483 → |
| 17 Sep 2018 – 26 Sep 2018 | Human Drugs | 483 | View 483 → |
| 10 May 2016 – 26 May 2016 | Human Drugs | 483 | View 483 → |
| 3 Mar 2015 – 13 Mar 2015 | Human Drugs | 483 | View 483 → |
| 15 Jul 2013 – 24 Jul 2013 | Human Drugs | 483 | On file |
| 15 Apr 2013 – 26 Apr 2013 | Medical Devices & Rad Health | 483 | On file |
| 26 Jan 2011 | Not recorded | 483 | On file |
| 9 Apr 2010 | Not recorded | 483 | On file |
| 17 Mar 2009 | Not recorded | 483 | View 483 → |
| 23 Apr 2008 | Not recorded | 483 | On file |
| 17 Aug 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Apr 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Edmund F Mrak, Frederick Razzaghi, Andrew O Ejiofor
3 Apr 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Edmund F Mrak, Frederick Razzaghi, Andrew O Ejiofor
3 Apr 2024
21 CFR 211.137(a)
Expiration date lacking
Cited by Edmund F Mrak, Frederick Razzaghi, Andrew O Ejiofor
3 Apr 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Edmund F Mrak, Frederick Razzaghi, Andrew O Ejiofor
3 Apr 2024
21 CFR 211.42(c)(10)(i)
Floors, walls, ceiling surfaces
Cited by Edmund F Mrak, Frederick Razzaghi, Andrew O Ejiofor
Investigators
FDA investigators tied to this site in the record.
Rachel C Harrington4 insp.
Brooke K Higgins3 insp.
Ernest Bizjak3 insp.
Edmund F Mrak1 insp.
Frederick Razzaghi1 insp.
Andrew O Ejiofor1 insp.
Marcellinus D Dordunoo1 insp.
Shirshendu K Deb1 insp.
William J Leonard1 insp.
Jonathan W Chapman1 insp.
Rebecca Rodriguez1 insp.
Steven P Donald1 insp.
Tajah L Blackburn1 insp.
Patricia A Morrow1 insp.
Shusheen A Alexander1 insp.
Laurissa S Flowers1 insp.
Sharon K Thoma1 insp.
Merideth K Rose1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bell-More Labs, Inc.'s 11 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