Eli Lilly Kinsale Limited
Form 483 issued March 16, 2018 · Kinsale, Ireland
- Inspection
- Mar 12 – Mar 16, 2018
- Investigators
- Laura Fontan· Milos Dokmanovic· Richard Ledwidge
- Observations
- 3
- Pages
- 4
- FEI number
- 3002806888
In short: On March 16, 2018, FDA issued a Form 483 with 3 observations to Eli Lilly Kinsale Limited in Kinsale, Co Cork (FEI 3002806888) after an inspection that ran Mar 12 – Mar 16, 2018. The investigators were Laura Fontan, Milos Dokmanovic and Richard Ledwidge. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.113 (1×) · 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
There is inadequate control to prevent microbial contamination in the…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Pharmacopeia…
This inspection in context
Laura Fontan
8 documents · 2017–2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmEli Lilly Kinsale Limited history
The site's inspection history, in date order.
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 Eli Lilly Kinsale Limited?
FDA listed 3 observations on this Form 483, mostly about production and quality system. 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 Eli Lilly Kinsale Limited?
Laura Fontan, Milos Dokmanovic and Richard Ledwidge are named on this Form 483, for the inspection of Mar 12 – Mar 16, 2018. Each investigator has a profile showing what they cite most.
When was Eli Lilly Kinsale Limited inspected by FDA?
The inspection ran Mar 12 – Mar 16, 2018, and the Form 483 is dated March 16, 2018.
How do I get the full Form 483 for Eli Lilly Kinsale Limited?
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.