Delpharm DIjon
Form 483 issued May 31, 2024 · Quetigny, France
- Inspection
- May 23 – May 31, 2024
- Investigator
- Jolanna A. Norton
- Observations
- 2
- Pages
- 2
- FEI number
- 3014120699
In short: On May 31, 2024, FDA issued a Form 483 with 2 observations to Delpharm DIjon in Quetigny, France (FEI 3014120699) after an inspection that ran May 23 – May 31, 2024. The investigator was Jolanna A. Norton. Most observations concern production; the most-cited regulation is 21 CFR 211.186 (master production and control records).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.186 (1×) · 211.111 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The master production and control records are deficient in that they do not include a statement…
- 02
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Jolanna A. Norton
22 documents · 2017–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmDelpharm DIjon history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.186
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Delpharm DIjon?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.186 (master production and control records). The opening words of each observation are shown on this page.
Who inspected Delpharm DIjon?
Jolanna A. Norton is named on this Form 483, for the inspection of May 23 – May 31, 2024. Each investigator has a profile showing what they cite most.
When was Delpharm DIjon inspected by FDA?
The inspection ran May 23 – May 31, 2024, and the Form 483 is dated May 31, 2024.
How do I get the full Form 483 for Delpharm DIjon?
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.