Terumo BCT Ltd.
Form 483 issued February 7, 2020 · Larne, United Kingdom
- Inspection
- Jan 30 – Feb 7, 2020
- Investigator
- Santos E. Camara
- Observations
- 2
- Pages
- 2
- FEI number
- 3002545766
In short: On February 7, 2020, FDA issued a Form 483 with 2 observations to Terumo BCT Ltd. in Larne, United Kingdom (FEI 3002545766) after an inspection that ran Jan 30 – Feb 7, 2020. The investigator was Santos E. Camara. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Batch production and control records do not include the specific identification of each batch of component…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Terumo BCT Ltd.?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Terumo BCT Ltd.?
Santos E. Camara is named on this Form 483, for the inspection of Jan 30 – Feb 7, 2020. Each investigator has a profile showing what they cite most.
When was Terumo BCT Ltd. inspected by FDA?
The inspection ran Jan 30 – Feb 7, 2020, and the Form 483 is dated February 7, 2020.
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.