Tosoh Bioscience Inc
FDA inspection history across 3 sites, 2016 to 2020
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2016: one warning letter and one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One warning letter and one Form 483, at San Francisco, California and Grove City, Ohio.
- 2020One close-out letter, at South San Francisco, California.
Cited most
Across all Tosoh Bioscience observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(c)Complaint files1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.50Purchasing controls1
- 21 CFR 820.70(g)(1)Production and process controls1
The complete Tosoh Bioscience 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
South San Francisco, California
One close-out letter · 2020
Latest: Close-out, Mar 25, 2020 →San Francisco, California
One warning letter · 2016
Latest: Warning letter, Aug 5, 2016 →Grove City, Ohio
One Form 483 · 2016 · 6 observations
Latest: Form 483, Jun 28, 2016 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-03-25 | Close-out Close-out letter | South San Francisco, California | — | $99 |
| 2016-08-05 | Warning letter Warning letter | San Francisco, California | — | $99 |
| 2016-06-28 | 483 Form 483 | Grove City, Ohio | 6 | $99 |
Investigators on these documents
FEI number 3005529799 · most recent document Mar 25, 2020
About Tosoh Bioscience Inc
How many FDA Form 483s has Tosoh Bioscience Inc received?
FDA Intel has 1 Form 483 on file for Tosoh Bioscience Inc; the most recent is dated Jun 28, 2016.
When was Tosoh Bioscience Inc last inspected by FDA?
The most recent FDA inspection document on file for Tosoh Bioscience Inc is a Form 483 dated Jun 28, 2016, for the site in Grove City, Ohio.
What did FDA cite at Tosoh Bioscience Inc?
The regulations cited most in the observations on file for Tosoh Bioscience Inc are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(c) (Complaint files), 1 time; 21 CFR 820.22 (Quality audit), 1 time.
Has Tosoh Bioscience Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Tosoh Bioscience Inc; the most recent is dated Aug 5, 2016.