Western / Scott Fetzer Company
FDA inspection history in Westlake, Ohio, 2014 to 2016
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one warning letter; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16One warning letter and one Form 483, at Westlake, Ohio.
Cited most
Across all Western / Scott Fetzer observations on file
- 21 CFR 820.100(b)Corrective and preventive action1
- 21 CFR 820.198(c)Complaint files1
- 21 CFR 820.50Purchasing controls1
- 21 CFR 820.75(a)Process validation1
The complete Western / Scott Fetzer file.
All 2 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
Westlake, Ohio
One Form 483 and one warning letter · 2014 to 2016 · 4 observations
Latest: Form 483, Aug 12, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-08-12 | 483 Form 483 | Westlake, Ohio | 4 | $99 |
| 2014-10-10 | Warning letter Warning letter | Westlake, Ohio | — | $99 |
Investigators on these documents
FEI number 1526809 · most recent document Aug 12, 2016
About Western / Scott Fetzer Company
How many FDA Form 483s has Western / Scott Fetzer Company received?
FDA Intel has 1 Form 483 on file for Western / Scott Fetzer Company; the most recent is dated Aug 12, 2016.
When was Western / Scott Fetzer Company last inspected by FDA?
The most recent FDA inspection document on file for Western / Scott Fetzer Company is a Form 483 dated Aug 12, 2016, for the site in Westlake, Ohio.
What did FDA cite at Western / Scott Fetzer Company?
The regulations cited most in the observations on file for Western / Scott Fetzer Company are 21 CFR 820.100(b) (Corrective and preventive action), 1 time; 21 CFR 820.198(c) (Complaint files), 1 time; 21 CFR 820.50 (Purchasing controls), 1 time.
Has Western / Scott Fetzer Company received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Western / Scott Fetzer Company; the most recent is dated Oct 10, 2014.