Terumo BCT Ltd.
FDA inspection history in Larne, United Kingdom, 2020 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Larne, United Kingdom.
- 2020The longest 483 on file: 2 observations over 2 pages at Larne, United Kingdom.
- 2023One Form 483, at Larne, United Kingdom.
Cited most
Across all Terumo BCT observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 820.75(b)Process validation1
The complete Terumo BCT 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
Larne, United Kingdom
Two Form 483s · 2020 to 2023 · 3 observations
Latest: Form 483, Jan 19, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-19 | 483 Form 483 | Larne, United Kingdom | 1 | $99 |
| 2020-02-07 | 483 Form 483 | Larne, United Kingdom | 2 | $99 |
Investigators on these documents
FEI number 3002545766 · most recent document Jan 19, 2023
About Terumo BCT Ltd.
How many FDA Form 483s has Terumo BCT Ltd. received?
FDA Intel has 2 Form 483s on file for Terumo BCT Ltd.; the most recent is dated Jan 19, 2023.
When was Terumo BCT Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Terumo BCT Ltd. is a Form 483 dated Jan 19, 2023, for the site in Larne, United Kingdom.
What did FDA cite at Terumo BCT Ltd.?
The regulations cited most in the observations on file for Terumo BCT Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time; 21 CFR 820.75(b) (Process validation), 1 time.