Medisca Inc.
FDA inspection history in Plattsburgh, New York, 2014 to 2016
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2014: one Form 483; 2015: one warning letter; 2016: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16One Form 483, one warning letter and one close-out letter, at Plattsburgh, New York.
Cited most
Across all Medisca observations on file
- 21 CFR 211.198Complaint files1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Medisca 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
Plattsburgh, New York
One warning letter and one Form 483 · 2014 to 2015 · 3 observations
Latest: Warning letter, Nov 25, 2015 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-05-24 | Close-out Close-out letter | — | — | $99 |
| 2015-11-25 | Warning letter Warning letter | Plattsburgh, New York | — | $99 |
| 2014-02-27 | 483 Form 483 | Plattsburgh, New York | 3 | $99 |
Investigators on these documents
FEI number 1000120311 · most recent document May 24, 2016
About Medisca Inc.
How many FDA Form 483s has Medisca Inc. received?
FDA Intel has 1 Form 483 on file for Medisca Inc.; the most recent is dated Feb 27, 2014.
When was Medisca Inc. last inspected by FDA?
The most recent FDA inspection document on file for Medisca Inc. is a Form 483 dated Feb 27, 2014, for the site in Plattsburgh, New York.
What did FDA cite at Medisca Inc.?
The regulations cited most in the observations on file for Medisca Inc. are 21 CFR 211.198 (Complaint files), 1 time; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 1 time.
Has Medisca Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Medisca Inc.; the most recent is dated Nov 25, 2015.