CELGENE CORPORATION
Form 483 issued June 16, 2023 · SUMMIT, New Jersey
- Inspection
- Jun 5 – Jun 16, 2023
- Investigator
- Helen B. Ricalde
- Observations
- 4
- Pages
- 4
- FEI number
- 3004991673
In short: On June 16, 2023, FDA issued a Form 483 with 4 observations to CELGENE CORPORATION in SUMMIT, New Jersey (FEI 3004991673) after an inspection that ran Jun 5 – Jun 16, 2023. The investigator was Helen B. Ricalde. Most observations concern facilities & equipment and packaging & labeling; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and packaging & labeling account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
This inspection in context
Helen B. Ricalde
9 documents · 2003–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 211.137(a)
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 facilities & equipment, packaging & labeling and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected CELGENE CORPORATION?
Helen B. Ricalde is named on this Form 483, for the inspection of Jun 5 – Jun 16, 2023. Each investigator has a profile showing what they cite most.
When was CELGENE CORPORATION inspected by FDA?
The inspection ran Jun 5 – Jun 16, 2023, and the Form 483 is dated June 16, 2023.
How do I get the full Form 483 for CELGENE CORPORATION?
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