Terumo BCT Ltd.
Form 483 issued January 19, 2023 · Larne, United Kingdom
- Inspection
- Jan 16 – Jan 19, 2023
- Investigator
- Maryam Tabatabaie
- Observations
- 1
- Pages
- 3
- FEI number
- 3002545766
In short: On January 19, 2023, FDA issued a Form 483 with 1 observation to Terumo BCT Ltd. in Larne, United Kingdom (FEI 3002545766) after an inspection that ran Jan 16 – Jan 19, 2023. The investigator was Maryam Tabatabaie. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for monitoring and control of process parameters for a validated process have…
This inspection in context
Maryam Tabatabaie
11 documents · 2016–2024
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Rhode Island.
The firmTerumo BCT Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Terumo BCT Ltd.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Terumo BCT Ltd.?
Maryam Tabatabaie is named on this Form 483, for the inspection of Jan 16 – Jan 19, 2023. Each investigator has a profile showing what they cite most.
When was Terumo BCT Ltd. inspected by FDA?
The inspection ran Jan 16 – Jan 19, 2023, and the Form 483 is dated January 19, 2023.
How do I get the full Form 483 for Terumo BCT Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.