Fareva Amboise
Form 483 issued May 25, 2018 · Poce-sur-Cisse, France
- Inspection
- May 21 – May 25, 2018
- Investigator
- Taichun Qin
- Observations
- 4
- Pages
- 4
- FEI number
- 3000234005
In short: On May 25, 2018, FDA issued a Form 483 with 4 observations to Fareva Amboise in Poce-sur-Cisse, France (FEI 3000234005) after an inspection that ran May 21 – May 25, 2018. The investigator was Taichun Qin. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks the responsibility and authority to approve and reject all components, drug…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
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 firmFareva Amboise history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fareva Amboise?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Fareva Amboise?
Taichun Qin is named on this Form 483, for the inspection of May 21 – May 25, 2018. Each investigator has a profile showing what they cite most.
When was Fareva Amboise inspected by FDA?
The inspection ran May 21 – May 25, 2018, and the Form 483 is dated May 25, 2018.
How do I get the full Form 483 for Fareva Amboise?
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.