Cytophil, Inc.
FDA inspection history in East Troy, Wisconsin, 2014 to 2022
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2014: one close-out letter and one warning letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One close-out letter and one warning letter, at East Troy, Wisconsin.
- 2022One Form 483, at East Troy, Wisconsin.
Cited most
Across all Cytophil observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.250(b)Statistical techniques1
- 21 CFR 820.30(g)Design controls1
- 21 CFR 820.75(a)Process validation1
- 21 CFR 820.90(a)Nonconforming product1
The complete Cytophil file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
East Troy, Wisconsin
One Form 483, one close-out letter and one warning letter · 2014 to 2022 · 5 observations
Latest: Form 483, Jul 29, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-29 | 483 Form 483 | East Troy, Wisconsin | 5 | $99 |
| 2014-10-24 | Close-out Close-out letter | East Troy, Wisconsin | — | $99 |
| 2014-04-01 | Warning letter Warning letter | East Troy, Wisconsin | — | $99 |
Investigators on these documents
FEI number 3007225376 · most recent document Jul 29, 2022
About Cytophil, Inc.
How many FDA Form 483s has Cytophil, Inc. received?
FDA Intel has 1 Form 483 on file for Cytophil, Inc.; the most recent is dated Jul 29, 2022.
When was Cytophil, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Cytophil, Inc. is a Form 483 dated Jul 29, 2022, for the site in East Troy, Wisconsin.
What did FDA cite at Cytophil, Inc.?
The regulations cited most in the observations on file for Cytophil, Inc. are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.250(b) (Statistical techniques), 1 time; 21 CFR 820.30(g) (Design controls), 1 time.
Has Cytophil, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Cytophil, Inc.; the most recent is dated Apr 1, 2014.