FDA Intel

CELGENE CORPORATION

Form 483 issued February 19, 2021 · SUMMIT, New Jersey

Inspection
Feb 15 – Feb 19, 2021
Observations
3
Pages
2
FEI number
3004991673

In short: On February 19, 2021, FDA issued a Form 483 with 3 observations to CELGENE CORPORATION in SUMMIT, New Jersey (FEI 3004991673) after an inspection that ran Feb 15 – Feb 19, 2021. Most observations concern production and quality system.

At a glance

Production and quality system account for 2 of 3 observations.

Production1
Quality system1
Biologics CGMP1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 211.113

    Written procedures designed to prevent objectionable microorganisms in drug…

  2. 02
    21 CFR 211.22

    The responsibilities and procedure applicable to the quality control unit…

  3. 03
    21 CFR 600.14

    There are no written procedures to link the process by which escalated deviations can initiate product…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The firm

CELGENE CORPORATION history

All 7 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at CELGENE CORPORATION?

FDA listed 3 observations on this Form 483, mostly about production, quality system and biologics CGMP. The opening words of each observation are shown on this page.

When was CELGENE CORPORATION inspected by FDA?

The inspection ran Feb 15 – Feb 19, 2021, and the Form 483 is dated February 19, 2021.

How do I get the full Form 483 for CELGENE CORPORATION?

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