Transdermal Cap Inc

FDA inspection history in Cleveland, Ohio, 2015

1
Warning letter
1
Form 483

Every document, by year

  • Warning letter
  • Form 483

2015: one warning letter and one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2015One warning letter and one Form 483, at Cleveland, Ohio.

Cited most

Across all Transdermal Cap observations on file

The complete Transdermal Cap file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2015-08-10Warning letter Warning letter$99
2015-06-30483 Form 483$99

Investigators on these documents

Laureen M. Geniusz (1)

FEI number 3008699663 · most recent document Aug 10, 2015

About Transdermal Cap Inc

How many FDA Form 483s has Transdermal Cap Inc received?

FDA Intel has 1 Form 483 on file for Transdermal Cap Inc; the most recent is dated Jun 30, 2015.

When was Transdermal Cap Inc last inspected by FDA?

The most recent FDA inspection document on file for Transdermal Cap Inc is a Form 483 dated Jun 30, 2015, for the site in Cleveland, Ohio.

What did FDA cite at Transdermal Cap Inc?

The regulations cited most in the observations on file for Transdermal Cap Inc are 21 CFR 820.30(f) (Design controls), 3 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time.

Has Transdermal Cap Inc received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Transdermal Cap Inc; the most recent is dated Aug 10, 2015.