Transdermal Cap Inc
Form 483 issued June 30, 2015 · Cleveland, Ohio
- Inspection
- Jun 11 – Jun 30, 2015
- Investigator
- Laureen M. Geniusz
- Observations
- 7
- Pages
- 8
- FEI number
- 3008699663
In short: On June 30, 2015, FDA issued a Form 483 with 7 observations to Transdermal Cap Inc in Cleveland, Ohio (FEI 3008699663) after an inspection that ran Jun 11 – Jun 30, 2015. The investigator was Laureen M. Geniusz. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 6 of 7 observations.
Most cited: 21 CFR 820.30(g) (2×)
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
Procedures for corrective and preventive action have…
- 03
Procedures have not been adequately established to control product that does not…
- 04
Procedures for design verification have…
This inspection in context
Laureen M. Geniusz
10 documents · 2015–2026
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Ohio.
The firmTransdermal Cap 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 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Transdermal Cap Inc?
FDA listed 7 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Transdermal Cap Inc?
Laureen M. Geniusz is named on this Form 483, for the inspection of Jun 11 – Jun 30, 2015. Each investigator has a profile showing what they cite most.
When was Transdermal Cap Inc inspected by FDA?
The inspection ran Jun 11 – Jun 30, 2015, and the Form 483 is dated June 30, 2015.
How do I get the full Form 483 for Transdermal Cap 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.