American Contract Systems, Inc
Form 483 issued October 4, 2019 · Houston, Texas
- Inspection
- Sep 9 – Oct 4, 2019
- Investigator
- Jocelyn C. Turner
- Observations
- 5
- Pages
- 15
- FEI number
- 3009189894
In short: On October 4, 2019, FDA issued a Form 483 with 5 observations to American Contract Systems, Inc in Houston, Texas (FEI 3009189894) after an inspection that ran Sep 9 – Oct 4, 2019. The investigator was Jocelyn C. Turner. Most observations concern production & process controls and records & documents; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
4 of 5 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for monitoring and control of process parameters for a validated process have not been adequately…
- 03
There is no documentation of the review and evaluation of a process performed in response to…
- 04
Software used as part of production has not been adequately validated for its intended use according…
This inspection in context
Jocelyn C. Turner
10 documents · 2015–2026
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmAmerican Contract Systems, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Contract Systems, Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls and records & documents. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected American Contract Systems, Inc?
Jocelyn C. Turner is named on this Form 483, for the inspection of Sep 9 – Oct 4, 2019. Each investigator has a profile showing what they cite most.
When was American Contract Systems, Inc inspected by FDA?
The inspection ran Sep 9 – Oct 4, 2019, and the Form 483 is dated October 4, 2019.
How do I get the full Form 483 for American Contract Systems, Inc?
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.