Del Medical, Inc
Form 483 issued March 19, 2021 · Bloomingdale, Illinois
- Inspection
- Feb 18 – Mar 19, 2021
- Investigator
- Amanda Dinaro
- Observations
- 5
- Pages
- 8
- FEI number
- 1418964
In short: On March 19, 2021, FDA issued a Form 483 with 5 observations to Del Medical, Inc in Bloomingdale, Illinois (FEI 1418964) after an inspection that ran Feb 18 – Mar 19, 2021. The investigator was Amanda Dinaro. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
4 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Records for complaints where no investigation was made do…
- 03
Procedures have not been established to control product that does not…
- 04
Procedures for rework of nonconforming product have…
This inspection in context
Amanda Dinaro
7 documents · 2017–2023
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Illinois.
The firmDel Medical, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Del Medical, Inc?
FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Del Medical, Inc?
Amanda Dinaro is named on this Form 483, for the inspection of Feb 18 – Mar 19, 2021. Each investigator has a profile showing what they cite most.
When was Del Medical, Inc inspected by FDA?
The inspection ran Feb 18 – Mar 19, 2021, and the Form 483 is dated March 19, 2021.
How do I get the full Form 483 for Del Medical, Inc?
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.