ACS Dobfar SpA
Form 483 issued October 29, 2024 · Castellalto, Italy
- Inspection
- Oct 21 – Oct 29, 2024
- Investigator
- Wayne D. McGrath
- Observations
- 1
- Pages
- 2
- FEI number
- 3030444500
In short: On October 29, 2024, FDA issued a Form 483 with 1 observation to ACS Dobfar SpA in Castellalto, Italy (FEI 3030444500) after an inspection that ran Oct 21 – Oct 29, 2024. The investigator was Wayne D. McGrath. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Wayne D. McGrath
33 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmACS Dobfar SpA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ACS Dobfar SpA?
FDA listed 1 observation on this Form 483, mostly about production. 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 ACS Dobfar SpA?
Wayne D. McGrath is named on this Form 483, for the inspection of Oct 21 – Oct 29, 2024. Each investigator has a profile showing what they cite most.
When was ACS Dobfar SpA inspected by FDA?
The inspection ran Oct 21 – Oct 29, 2024, and the Form 483 is dated October 29, 2024.
How do I get the full Form 483 for ACS Dobfar SpA?
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.