Astrea Monts
Form 483 issued February 26, 2013 · Monts, France
- Inspection
- Feb 18 – Feb 26, 2013
- Investigator
- S. Lori Brown
- Observations
- 5
- Pages
- 3
- FEI number
- 1000171152
In short: On February 26, 2013, FDA issued a Form 483 with 5 observations to Astrea Monts in Monts, France (FEI 1000171152) after an inspection that ran Feb 18 – Feb 26, 2013. The investigator was S. Lori Brown. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
- 03
Written procedures are not followed that describe the examinations to be conducted on appropriate samples of…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
S. Lori Brown
1 document · 2013
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in France.
The firmAstrea Monts history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Astrea Monts?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Astrea Monts?
S. Lori Brown is named on this Form 483, for the inspection of Feb 18 – Feb 26, 2013. Each investigator has a profile showing what they cite most.
When was Astrea Monts inspected by FDA?
The inspection ran Feb 18 – Feb 26, 2013, and the Form 483 is dated February 26, 2013.
How do I get the full Form 483 for Astrea Monts?
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.