Overview
- 12 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-10-13.
At a glance
Inspections
12
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Oct 2022 – 13 Oct 2022 | Human Drugs | Clean | |
| 21 Sep 2018 – 28 Sep 2018 | Human Drugs | 483 | On file |
| 5 Sep 2018 | Human Drugs | Clean | |
| 10 Mar 2018 | Human Drugs | Clean | |
| 27 Mar 2017 – 31 Mar 2017 | Human Drugs | 483 | On file |
| 16 Jun 2016 – 24 Jun 2016 | Human Drugs | 483 | View 483 → |
| 27 Oct 2014 – 4 Nov 2014 | Human Drugs | 483 | On file |
| 24 Sep 2012 | Not recorded | 483 | On file |
| 9 May 2009 | Not recorded | 483 | On file |
| 30 Aug 2002 | Not recorded | Clean | |
| 31 Mar 2000 | Not recorded | Clean | |
| 2 Feb 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jun 2016
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Lynda L Perry, Ademola O Daramola
24 Jun 2016
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Lynda L Perry, Ademola O Daramola
24 Jun 2016
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Lynda L Perry, Ademola O Daramola
Investigators
FDA investigators tied to this site in the record.
MRA DavisM2 insp.
MRA MunizN1 insp.
Scott R Nichols1 insp.
Thuy T Nguyen1 insp.
Maria J Lopez- Barragan1 insp.
Lynda L Perry1 insp.
Ademola O Daramola1 insp.
Reyes Candau-Chacon1 insp.
Mihaly S Ligmond1 insp.
Bo Chi1 insp.
Mary E Farbman1 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 | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lonza Biologics, plc's 6 Form 483s
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