Overview
- 13 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-22.
At a glance
Inspections
13
Form 483s
10
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Nov 2024 – 22 Nov 2024 | Biologics | 483 | View 483 → |
| 20 May 2019 – 31 May 2019 | Biologics | 483 | On file |
| 9 Jan 2017 – 19 Jan 2017 | Biologics | 483 | On file |
| 16 Feb 2015 – 24 Feb 2015 | Biologics | 483 | On file |
| 15 Oct 2014 – 23 Oct 2014 | Biologics | 483 | On file |
| 10 Jun 2013 – 18 Jun 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Mar 2013 – 19 Mar 2013 | Biologics | 483 | On file |
| 21 Jan 2011 | Not recorded | 483 | On file |
| 19 Oct 2009 | Not recorded | 483 | On file |
| 18 Jan 2008 | Not recorded | 483 | On file |
| 14 Jun 2005 | Not recorded | Clean | |
| 24 Jun 2003 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Nov 2024
21 CFR 211.188(b)(2)
Identification of Equipment and Lines
Cited by Shafiq Ahadi, Alan L Truong, Malgorzata G Norton
18 Jun 2013
21 CFR 211.25(a)
GMP Training Frequency
Cited by Michele Perry-Williams, Freddy Ortiz Colon
18 Jun 2013
21 CFR 211.110(a)
Written in-process control procedures
Cited by Michele Perry-Williams, Freddy Ortiz Colon
18 Jun 2013
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Michele Perry-Williams, Freddy Ortiz Colon
18 Jun 2013
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Michele Perry-Williams, Freddy Ortiz Colon
Investigators
FDA investigators tied to this site in the record.
Prabhu P Raju2 insp.
Jacqueline M Diaz Albert2 insp.
Paula A Trost2 insp.
Shafiq Ahadi1 insp.
Alan L Truong1 insp.
Malgorzata G Norton1 insp.
Mizanne E Lewis1 insp.
Yonggang Wang1 insp.
Simone E Pitts1 insp.
Burnell M Henry1 insp.
Randa Melhem1 insp.
Jeremy L Wally1 insp.
Michele Perry-Williams1 insp.
Freddy Ortiz Colon1 insp.
Omotunde O Osunsanmi1 insp.
Christian Lynch1 insp.
Mihaly S Ligmond1 insp.
Rose M Ashley1 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 | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Baxalta Belgium Manufacturing SA's 10 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