Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-02-16.
At a glance
Inspections
5
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Feb 2019 – 16 Feb 2019 | Biologics | 483 | On file |
| 13 Mar 2017 – 22 Mar 2017 | Biologics | 483 | On file |
| 11 May 2016 – 18 May 2016 | Biologics | 483 | On file |
| 7 Apr 2015 – 17 Apr 2015 | Biologics | 483 | On file |
| 27 May 2011 | Not recorded | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
Gene D Arcy2 insp.
Debra M Emerson1 insp.
Christine Harman1 insp.
Quyen T Tran1 insp.
Mihaly S Ligmond1 insp.
Marion Michaelis1 insp.
Ellen Huang1 insp.
Nawab A Siddiqui1 insp.
Full site report
Get the verbatim findings behind Cangene BioPharma, LLC.'s 5 Form 483s
The full inspection record, as Atlas holds it, 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