Astrea Monts
Form 483 issued November 12, 2019 · Monts, France
- Inspection
- Nov 5 – Nov 12, 2019
- Investigator
- Christopher Keating
- Observations
- 1
- Pages
- 1
- FEI number
- 1000171152
In short: On November 12, 2019, FDA issued a Form 483 with 1 observation to Astrea Monts in Monts, lodrc Et Loire (FEI 1000171152) after an inspection that ran Nov 5 – Nov 12, 2019. The investigator was Christopher Keating. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records of the inspections of automatic, mechanical or electronic equipment, including computers or related…
This inspection in context
Christopher Keating
13 documents · 2018–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Astrea Monts?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Astrea Monts?
Christopher Keating is named on this Form 483, for the inspection of Nov 5 – Nov 12, 2019. Each investigator has a profile showing what they cite most.
When was Astrea Monts inspected by FDA?
The inspection ran Nov 5 – Nov 12, 2019, and the Form 483 is dated November 12, 2019.
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.