CELGENE CORPORATION
Form 483 issued March 19, 2010 · SUMMIT, New Jersey
- Inspection
- Mar 3 – Mar 19, 2010
- Investigator
- Alberto A. Viciedo
- Observations
- 4
- Pages
- 3
- FEI number
- 3004991673
In short: On March 19, 2010, FDA issued a Form 483 with 4 observations to CELGENE CORPORATION in SUMMIT, New Jersey (FEI 3004991673) after an inspection that ran Mar 3 – Mar 19, 2010. The investigator was Alberto A. Viciedo. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Deviations from written production and process control…
- 04
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Alberto A. Viciedo
2 documents · 2009–2010
Cites 110.37(b)(2) (sanitary facilities and controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmCELGENE CORPORATION history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CELGENE CORPORATION?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected CELGENE CORPORATION?
Alberto A. Viciedo is named on this Form 483, for the inspection of Mar 3 – Mar 19, 2010. Each investigator has a profile showing what they cite most.
When was CELGENE CORPORATION inspected by FDA?
The inspection ran Mar 3 – Mar 19, 2010, and the Form 483 is dated March 19, 2010.
How do I get the full Form 483 for CELGENE CORPORATION?
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.