Drug factory · FDA FEI 3002781621

Seagen Inc.

21823 30th Drive SE, Bothell, WA, 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 13, 2025 inspection

• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the packing of a drug product lack the training required to perform their assigned functions.

May 1, 2017 inspection

• Review of Adverse Experiences - SOPs 21 CFR 600.80(b)
  There are no written procedures for the receipt, evaluation and reporting of post-marketing adverse experiences to FDA.
• Reporting Requirements - 15-day alert 21 CFR 600.80(c)(1)(i)
  All serious and unexpected adverse experiences were not reported within 15 calendar day of initial receipt of the information.

Jun 9, 2015 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not justified.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established specifications, standards, and laboratory control mechanisms are not documented at the time of performance.
• Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
  All records of production and control associated with a batch of drug product are not maintained at least one (1) year after the expiration date.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
• Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
  Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.

Mar 20, 2013 inspection

• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit.
• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit.
• Test methods 21 CFR 211.165(e)
  The reproducibility of test methods have not been established.
• Test methods 21 CFR 211.165(e)
  The reproducibility of test methods have not been established.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing.
• Failure to develop written procedures 21 CFR 314.80(b)
  Written procedures have not been developed for the receipt of post marketing adverse drug experiences.
• Failure to develop written procedures 21 CFR 314.80(b)
  Written procedures have not been developed for the receipt of post marketing adverse drug experiences.

Registered with FDA for: analysis.