Form 483 · FEI 3003110073
Form 483 issued December 10, 2015 · Dagneux, France
- Inspection
- Dec 7 – Dec 10, 2015
- Investigator
- Phillip M. Pontikos
- Observations
- 4
- Pages
- 3
- FEI number
- 3003110073
In short: On December 10, 2015, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Dagneux, France (FEI 3003110073) after an inspection that ran Dec 7 – Dec 10, 2015. The investigator was Phillip M. Pontikos. Most observations concern production & process controls and cAPA.
At a glance
Observations span 3 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures to ensure equipment is routinely calibrated have…
- 02
Procedures have not been adequately established to control product that does not…
- 03
Procedures for quality audits have…
- 0421 CFR 820
Observation 4: scanned text, readable in the full document.
This inspection in context
Phillip M. Pontikos
5 documents · 2015–2019
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in France.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.72
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Phillip M. Pontikos is named on this Form 483, for the inspection of Dec 7 – Dec 10, 2015. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Dec 7 – Dec 10, 2015, and the Form 483 is dated December 10, 2015.
How do I get the full Form 483 for an FDA-inspected site?
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.