ZACH SYSTEM S.A.
Form 483 issued October 25, 2018 · AVRILLE, France
- Inspection
- Oct 22 – Oct 25, 2018
- Investigator
- Scott Ballard
- Observations
- 2
- Pages
- 1
- FEI number
- 3002808164
In short: On October 25, 2018, FDA issued a Form 483 with 2 observations to ZACH SYSTEM S.A. in AVRILLE, France (FEI 3002808164) after an inspection that ran Oct 22 – Oct 25, 2018. The investigator was Scott Ballard. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by…
- 02
Specifically, your firm's electronic systems for storing data on product analysis do not always have unique…
This inspection in context
Scott Ballard
30 documents · 2011–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmZACH SYSTEM S.A. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ZACH SYSTEM S.A.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected ZACH SYSTEM S.A.?
Scott Ballard is named on this Form 483, for the inspection of Oct 22 – Oct 25, 2018. Each investigator has a profile showing what they cite most.
When was ZACH SYSTEM S.A. inspected by FDA?
The inspection ran Oct 22 – Oct 25, 2018, and the Form 483 is dated October 25, 2018.
How do I get the full Form 483 for ZACH SYSTEM S.A.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.