Parfums Christian Dior
Form 483 issued June 13, 2014 · Saint Jean de Braye, France
- Inspection
- Jun 10 – Jun 13, 2014
- Investigator
- Frederick Razzaghi
- Observations
- 3
- Pages
- 2
- FEI number
- 3000300581
In short: On June 13, 2014, FDA issued a Form 483 with 3 observations to Parfums Christian Dior in Saint Jean de Braye, Loiret (FEI 3000300581) after an inspection that ran Jun 10 – Jun 13, 2014. The investigator was Frederick Razzaghi. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 3 observations.
Most cited: 21 CFR 211.192 (1×) · 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Serious adverse event(s) for a non-prescription drug used in the United States has not been…
- 03
Batch production and control records for each batch of drug product produced do not include an…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Parfums Christian Dior?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Parfums Christian Dior?
Frederick Razzaghi is named on this Form 483, for the inspection of Jun 10 – Jun 13, 2014. Each investigator has a profile showing what they cite most.
When was Parfums Christian Dior inspected by FDA?
The inspection ran Jun 10 – Jun 13, 2014, and the Form 483 is dated June 13, 2014.
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.