Sandoz Canada, Inc

FDA inspection history in Boucherville, Canada, 2011 to 2014

1
Close-out
1
Form 483

Every document, by year

  • Close-out
  • Form 483

2011: one Form 483; 2014: one close-out letter.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2011One Form 483, at Boucherville, Canada.
  2. 2014One close-out letter, at Boucherville, Canada.

Cited most

Across all Sandoz Canada observations on file

The complete Sandoz Canada 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
2014-07-16Close-out Close-out letter$99
2011-08-04483 Form 483$99

Investigators on these documents

Sharon K. Thoma (1)

FEI number 3000280957 · most recent document Jul 16, 2014

About Sandoz Canada, Inc

How many FDA Form 483s has Sandoz Canada, Inc received?

FDA Intel has 1 Form 483 on file for Sandoz Canada, Inc; the most recent is dated Aug 4, 2011.

When was Sandoz Canada, Inc last inspected by FDA?

The most recent FDA inspection document on file for Sandoz Canada, Inc is a Form 483 dated Aug 4, 2011, for the site in Boucherville, Canada.

What did FDA cite at Sandoz Canada, Inc?

The regulations cited most in the observations on file for Sandoz Canada, Inc are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.198 (Complaint files), 1 time.