Celgene Chemicals, GmbH
Form 483 issued January 29, 2016 · Zofingen, Switzerland
- Inspection
- Jan 25 – Jan 29, 2016
- Investigator
- Linda F. Murphy
- Observations
- 3
- Pages
- 3
- FEI number
- 3006305265
In short: On January 29, 2016, FDA issued a Form 483 with 3 observations to Celgene Chemicals, GmbH in Zofingen, Switzerland (FEI 3006305265) after an inspection that ran Jan 25 – Jan 29, 2016. The investigator was Linda F. Murphy. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Results generated from a laboratory instrument which failed to meet established system suitability…
- 02
The maximum time that may elapse between the completion of processing and equipment cleaning…
- 03
Procedures applicable to the quality unit…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmCelgene Chemicals, GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Celgene Chemicals, GmbH?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Celgene Chemicals, GmbH?
Linda F. Murphy is named on this Form 483, for the inspection of Jan 25 – Jan 29, 2016. Each investigator has a profile showing what they cite most.
When was Celgene Chemicals, GmbH inspected by FDA?
The inspection ran Jan 25 – Jan 29, 2016, and the Form 483 is dated January 29, 2016.
How do I get the full Form 483 for Celgene Chemicals, GmbH?
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.