Astrea Monts
Form 483 issued June 9, 2015 · Monts, France
- Inspection
- Jun 1 – Jun 9, 2015
- Investigators
- Michael E. Maselli· Nadeem I. Chaudhry
- Observations
- 3
- Pages
- 3
- FEI number
- 1000171152
In short: On June 9, 2015, FDA issued a Form 483 with 3 observations to Astrea Monts in Monts, France (FEI 1000171152) after an inspection that ran Jun 1 – Jun 9, 2015. The investigators were Michael E. Maselli and Nadeem I. Chaudhry. Most observations concern materials and facilities & equipment.
At a glance
Materials and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There was a failure to handle and store components and drug product containers at all times…
- 02
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Michael E. Maselli
6 documents · 2015–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Colorado.
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 211.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Astrea Monts?
FDA listed 3 observations on this Form 483, mostly about materials, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Astrea Monts?
Michael E. Maselli and Nadeem I. Chaudhry are named on this Form 483, for the inspection of Jun 1 – Jun 9, 2015. Each investigator has a profile showing what they cite most.
When was Astrea Monts inspected by FDA?
The inspection ran Jun 1 – Jun 9, 2015, and the Form 483 is dated June 9, 2015.
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.