Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-08-05.
At a glance
Inspections
6
Form 483s
6
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Jul 2022 – 5 Aug 2022 | Human Drugs | 483 | View 483 → |
| 21 Jan 2020 – 24 Jan 2020 | Human Drugs | 483 | On file |
| 23 Jul 2018 – 27 Jul 2018 | Human Drugs | 483 | View 483 → |
| 26 Jun 2017 – 30 Jun 2017 | Human Drugs | 483 | View 483 → |
| 16 May 2016 – 3 Jun 2016 | Human Drugs | 483 | View 483 → |
| 9 Sep 2015 – 17 Sep 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Aug 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Nathaniel B Phillips Sylvain, Crystal Monroy
5 Aug 2022
21 CFR 211.166(a)
Written program not followed
Cited by Nathaniel B Phillips Sylvain, Crystal Monroy
5 Aug 2022
21 CFR 211.192
Written record of investigation incomplete
Cited by Nathaniel B Phillips Sylvain, Crystal Monroy
Investigators
FDA investigators tied to this site in the record.
Robert D Tollefsen2 insp.
Anita Narula2 insp.
Nathaniel B Phillips Sylvain1 insp.
Crystal Monroy1 insp.
Nicholas L Hunt1 insp.
Anissa M Vargas1 insp.
Zachary L Stamm1 insp.
Amanda L Fyles1 insp.
Carrie A Hughes1 insp.
Vioela J Caze1 insp.
Tracy K Li1 insp.
Christopher R Czajka1 insp.
Marijo B Kambere1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lonza Bend 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