Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-20.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Feb 2026 – 20 Feb 2026 | Biologics | 483 | View 483 → |
| 10 Dec 2024 – 13 Dec 2024 | Human Drugs | Clean | |
| 16 Sep 2024 – 19 Sep 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Jan 2020 – 31 Jan 2020 | Human Drugs | Clean | |
| 11 Dec 2017 – 15 Dec 2017 | Human Drugs | Clean | |
| 7 Mar 2016 – 11 Mar 2016 | Human Drugs | 483 | On file |
| 23 Feb 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Feb 2026
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Lewis K Antwi, Peng Zhou
20 Feb 2026
21 CFR 211.68(b)
Computer control of master formula records
Cited by Lewis K Antwi, Peng Zhou
Investigators
FDA investigators tied to this site in the record.
Lewis K Antwi1 insp.
Peng Zhou1 insp.
MRA M BarbosaR1 insp.
Maryam Tabatabaie1 insp.
Andrew J Barrowcliff1 insp.
Jai P Singh1 insp.
Robert C Steyert1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 820.70(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ENESTIA BELGIUM NV (SHARP BELGIUM)'s 3 Form 483s
Source PDFs 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