Delcon Srl
Form 483 issued March 24, 2023
- Inspection
- Mar 20 – Mar 24, 2023
- Investigator
- Travis S. Bradley
- Observations
- 2
- Pages
- 4
- FEI number
- 3014345398
In short: On March 24, 2023, FDA issued a Form 483 with 2 observations to Delcon Srl (FEI 3014345398) after an inspection that ran Mar 20 – Mar 24, 2023. The investigator was Travis S. Bradley. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (1×) · 820.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Corrective and preventive action activities and/or results…
This inspection in context
Travis S. Bradley
12 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Switzerland.
The firmDelcon Srl history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Delcon Srl?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Delcon Srl?
Travis S. Bradley is named on this Form 483, for the inspection of Mar 20 – Mar 24, 2023. Each investigator has a profile showing what they cite most.
When was Delcon Srl inspected by FDA?
The inspection ran Mar 20 – Mar 24, 2023, and the Form 483 is dated March 24, 2023.
How do I get the full Form 483 for Delcon Srl?
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.