Celgene International Sarl
Form 483 issued June 16, 2023 · Boudry, Switzerland
- Inspection
- Jun 12 – Jun 16, 2023
- Investigator
- Camerson E. Moore
- Observations
- 1
- Pages
- 2
- FEI number
- 3006323509
In short: On June 16, 2023, FDA issued a Form 483 with 1 observation to Celgene International Sarl in Boudry, Switzerland (FEI 3006323509) after an inspection that ran Jun 12 – Jun 16, 2023. The investigator was Camerson E. Moore. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmCelgene International Sarl history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Celgene International Sarl?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Celgene International Sarl?
Camerson E. Moore is named on this Form 483, for the inspection of Jun 12 – Jun 16, 2023. Each investigator has a profile showing what they cite most.
When was Celgene International Sarl inspected by FDA?
The inspection ran Jun 12 – Jun 16, 2023, and the Form 483 is dated June 16, 2023.
How do I get the full Form 483 for Celgene International Sarl?
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.