Astrea Monts
Form 483 issued October 18, 2022 · Monts, France
- Inspection
- Oct 10 – Oct 18, 2022
- Investigator
- Sandra A. Boyd
- Observations
- 10
- Pages
- 6
- FEI number
- 1000171152
In short: On October 18, 2022, FDA issued a Form 483 with 10 observations to Astrea Monts in Monts, France (FEI 1000171152) after an inspection that ran Oct 10 – Oct 18, 2022. The investigator was Sandra A. Boyd. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 10 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the…
This inspection in context
Sandra A. Boyd
16 documents · 2019–2026
Cites 211.113 (control of microbiological contamination) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Astrea Monts?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Astrea Monts?
Sandra A. Boyd is named on this Form 483, for the inspection of Oct 10 – Oct 18, 2022. Each investigator has a profile showing what they cite most.
When was Astrea Monts inspected by FDA?
The inspection ran Oct 10 – Oct 18, 2022, and the Form 483 is dated October 18, 2022.
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.