Taiwan Biotech Co, Ltd
FDA inspection history in Taoyuan City, Taiwan, 2017 to 2022
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2017: one Form 483; 2018: one close-out letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18One Form 483 and one close-out letter, at Taoyuan City, Taiwan.
- 2017The longest 483 on file: 4 observations over 4 pages at Taoyuan City, Taiwan.
- 2022One Form 483, at Taoyuan City, Taiwan.
Cited most
Across all Taiwan Biotech Co observations on file
- 21 CFR 211.166Stability testing2
- 21 CFR 211.180(e)General requirements2
- 21 CFR 211.137Expiration dating1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.42(c)(10)(iv)Design and construction features1
The complete Taiwan Biotech Co 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
Taoyuan City, Taiwan
Two Form 483s and one close-out letter · 2017 to 2022 · 6 observations
Latest: Form 483, Sep 20, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-20 | 483 Form 483 | Taoyuan City, Taiwan | 2 | $99 |
| 2018-05-31 | Close-out Close-out letter | Taoyuan City, Taiwan | — | $99 |
| 2017-09-11 | 483 Form 483 | Taoyuan City, Taiwan | 4 | $99 |
Investigators on these documents
FEI number 3003598505 · most recent document Sep 20, 2022
About Taiwan Biotech Co, Ltd
How many FDA Form 483s has Taiwan Biotech Co, Ltd received?
FDA Intel has 2 Form 483s on file for Taiwan Biotech Co, Ltd; the most recent is dated Sep 20, 2022.
When was Taiwan Biotech Co, Ltd last inspected by FDA?
The most recent FDA inspection document on file for Taiwan Biotech Co, Ltd is a Form 483 dated Sep 20, 2022, for the site in Taoyuan City, Taiwan.
What did FDA cite at Taiwan Biotech Co, Ltd?
The regulations cited most in the observations on file for Taiwan Biotech Co, Ltd are 21 CFR 211.166 (Stability testing), 2 times; 21 CFR 211.180(e) (General requirements), 2 times; 21 CFR 211.137 (Expiration dating), 1 time.