Janssen Sciences Ireland UC
Form 483 issued April 30, 2021 · Cork, Ireland
- Inspection
- Apr 26 – Apr 30, 2021
- Investigators
- Madushini Dharmasena· Sarah Johnson
- Observations
- 1
- Pages
- 1
- FEI number
- 3007029098
In short: On April 30, 2021, FDA issued a Form 483 with 1 observation to Janssen Sciences Ireland UC in Cork, CO (FEI 3007029098) after an inspection that ran Apr 26 – Apr 30, 2021. The investigators were Madushini Dharmasena and Sarah Johnson. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The invalid assays are not adequately investigated. Although SOPs for Management of Laboratory Issues in the…
This inspection in context
Madushini Dharmasena
13 documents · 2019–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmJanssen Sciences Ireland UC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Janssen Sciences Ireland UC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Janssen Sciences Ireland UC?
Madushini Dharmasena and Sarah Johnson are named on this Form 483, for the inspection of Apr 26 – Apr 30, 2021. Each investigator has a profile showing what they cite most.
When was Janssen Sciences Ireland UC inspected by FDA?
The inspection ran Apr 26 – Apr 30, 2021, and the Form 483 is dated April 30, 2021.
How do I get the full Form 483 for Janssen Sciences Ireland UC?
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.