Parfums Christian Dior
Form 483 issued June 8, 2018 · Saint Jean de Braye, France
- Inspection
- Jun 4 – Jun 8, 2018
- Investigator
- Taichun Qin
- Observations
- 8
- Pages
- 6
- FEI number
- 3000300581
In short: On June 8, 2018, FDA issued a Form 483 with 8 observations to Parfums Christian Dior in Saint Jean de Braye, Loiret (FEI 3000300581) after an inspection that ran Jun 4 – Jun 8, 2018. The investigator was Taichun Qin. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Equipment and utensils are not at appropriate intervals to prevent that would alter the safety, identity…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmParfums Christian Dior history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Parfums Christian Dior?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Parfums Christian Dior?
Taichun Qin is named on this Form 483, for the inspection of Jun 4 – Jun 8, 2018. Each investigator has a profile showing what they cite most.
When was Parfums Christian Dior inspected by FDA?
The inspection ran Jun 4 – Jun 8, 2018, and the Form 483 is dated June 8, 2018.
How do I get the full Form 483 for Parfums Christian Dior?
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.