Fareva Amboise
Form 483 issued September 16, 2025 · Poce Sur Cisse, France
- Inspection
- Sep 8 – Sep 16, 2025
- Investigators
- Justin A. Boyd· Karen A. Briggs· Vivin George
- Observations
- 9
- Pages
- 16
- FEI number
- 3000234005
In short: On September 16, 2025, FDA issued a Form 483 with 9 observations to Fareva Amboise in Poce Sur Cisse, France (FEI 3000234005) after an inspection that ran Sep 8 – Sep 16, 2025. The investigators were Justin A. Boyd, Karen A. Briggs and Vivin George. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 9 of 9 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile did not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fareva Amboise?
FDA listed 9 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Fareva Amboise?
Justin A. Boyd, Karen A. Briggs and Vivin George are named on this Form 483, for the inspection of Sep 8 – Sep 16, 2025. Each investigator has a profile showing what they cite most.
When was Fareva Amboise inspected by FDA?
The inspection ran Sep 8 – Sep 16, 2025, and the Form 483 is dated September 16, 2025.
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.