Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-27.
At a glance
Inspections
5
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 27 Feb 2026 | Biologics | 483 | View 483 → |
| 5 Jun 2023 – 23 Jun 2023 | Biologics | Clean | |
| 7 Oct 2019 – 11 Oct 2019 | Biologics | Clean | |
| 3 Jun 2019 – 24 Jun 2019 | Biologics | 483 | On file |
| 11 Apr 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Feb 2026
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Shafiq Ahadi, Thai D Truong
27 Feb 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Shafiq Ahadi, Thai D Truong
27 Feb 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Shafiq Ahadi, Thai D Truong
27 Feb 2026
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Shafiq Ahadi, Thai D Truong
Investigators
FDA investigators tied to this site in the record.
Shafiq Ahadi1 insp.
Thai D Truong1 insp.
Roger F Zabinski1 insp.
Burnell M Henry1 insp.
Deborah M Trout1 insp.
Gregory A Price1 insp.
Tod J Merkel1 insp.
Debra M Emerson1 insp.
Susan M Jackson1 insp.
Leslie D Wagner1 insp.
Shuang Tang1 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 | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | 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 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GlaxoSmithKline Biologicals SA's 2 Form 483s
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