Kiltex Corporation
Form 483 issued May 19, 2015 · Akron, Ohio
- Inspection
- May 13 – May 19, 2015
- Investigator
- Benjamin Dastoli
- Observations
- 5
- Pages
- 4
- FEI number
- 1527493
In short: On May 19, 2015, FDA issued a Form 483 with 5 observations to Kiltex Corporation in Akron, Ohio (FEI 1527493) after an inspection that ran May 13 – May 19, 2015. The investigator was Benjamin Dastoli. Most observations concern cAPA and production & process controls.
At a glance
3 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been adequately established to control product that does not…
- 02
Corrective aud preventive action activities and/or results have not…
- 03
Written MDR procedures have…
- 04
Process validation activities and results…
This inspection in context
Benjamin Dastoli
12 documents · 2009–2023
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Ohio.
The firmKiltex Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kiltex Corporation?
FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Kiltex Corporation?
Benjamin Dastoli is named on this Form 483, for the inspection of May 13 – May 19, 2015. Each investigator has a profile showing what they cite most.
When was Kiltex Corporation inspected by FDA?
The inspection ran May 13 – May 19, 2015, and the Form 483 is dated May 19, 2015.
How do I get the full Form 483 for Kiltex Corporation?
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.