INEX Silicone
Form 483 issued February 4, 2016 · Puiseux le Hauberger, France
- Inspection
- Feb 1 – Feb 4, 2016
- Investigator
- Shaquenta Y. Perkins
- Observations
- 1
- Pages
- 2
- FEI number
- 3007279404
In short: On February 4, 2016, FDA issued a Form 483 with 1 observation to INEX Silicone in Puiseux le Hauberger, France (FEI 3007279404) after an inspection that ran Feb 1 – Feb 4, 2016. The investigator was Shaquenta Y. Perkins. Most observations concern records & documents; the most-cited regulation is 21 CFR 820.40 (document controls).
At a glance
1 of 1 observations on this 483 concern records & documents.
Most cited: 21 CFR 820.40 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Document control procedures have…
This inspection in context
Shaquenta Y. Perkins
5 documents · 2015–2018
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in California.
The firmINEX Silicone history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.40
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at INEX Silicone?
FDA listed 1 observation on this Form 483, mostly about records & documents. The most-cited regulation is 21 CFR 820.40 (document controls). The opening words of each observation are shown on this page.
Who inspected INEX Silicone?
Shaquenta Y. Perkins is named on this Form 483, for the inspection of Feb 1 – Feb 4, 2016. Each investigator has a profile showing what they cite most.
When was INEX Silicone inspected by FDA?
The inspection ran Feb 1 – Feb 4, 2016, and the Form 483 is dated February 4, 2016.
How do I get the full Form 483 for INEX Silicone?
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.