Drug factory · FDA FEI 2917293

Genentech, Inc.

1 DNA Way, South San Francisco, CA, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

May 2, 2024 inspection

• Failure to comply with REMS Implementation System FDCA 505-1(f)(4)
  An application holder did not maintain a Support / Call Center or a REMS Program website, as required by your approved REMS Implementation System.
• Failure to comply with REMS Implementation System FDCA 505-1(f)(4)
  An application holder did not maintain a Support / Call Center or a REMS Program website, as required by your approved REMS Implementation System.

Mar 12, 2024 inspection

• General responsibilities of sponsors 21 CFR 312.50
  Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan.
• IND safety report 21 CFR 312.56(c)
  Failure to provide all participating investigators with an adequate written IND safety report.
• Records of receipt, shipment, disposition 21 CFR 312.57(a)
  Lack of records covering receipt and disposition of an investigational drug.

Aug 11, 2023 inspection

• Notification of FDA of termination of investigator 21 CFR 312.56(b)
  Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation.

Jul 8, 2016 inspection

• Records reviewed annually 21 CFR 211.180(e)
  Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to fully investigate errors that have occurred.

Registered with FDA for: analysis; api manufacture; label; manufacture; pack.