Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-10-25.
At a glance
Inspections
6
Form 483s
2
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Oct 2018 – 25 Oct 2018 | Human Drugs | 483 | On file |
| 5 Dec 2017 – 7 Dec 2017 | Human Drugs | Clean | |
| 10 Oct 2014 – 16 Oct 2014 | Human Drugs | Clean | |
| 2 Dec 2010 | Not recorded | Clean | |
| 11 Jun 2009 | Not recorded | WL | On file |
| 14 Apr 2005 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Scott T Ballard1 insp.
MRA McCulloughJ1 insp.
Nicole E Knowlton1 insp.
Eric L Dong1 insp.
Barbara M Frazier1 insp.
Rebecca Parrilla1 insp.
Full site report
Get the verbatim findings behind Zach System S.A.'s 2 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