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FDA Inspection
•Lonza Bend Inc•July 27, 2018

Lonza Bend Inc – FDA Inspection, Jul 27, 2018

Record Details

This FDA Inspection record concerns Lonza Bend Inc, with an inspection on July 27, 2018, issued by the Seattle District Office, covering human drugs.

Company
Lonza Bend Inc
Inspection Date
July 27, 2018
Product Type
Human Drugs
Office
Seattle District Office
People
  • Amanda L. Fyles (Company Rep)
  • Zachary L. Stamm (FDA Associated Person)
View Company Profile

ID · c76c00f8-e2a1-4545-ac99-a0d4e175830a

Inspection Facts

Inspection number
1060951
FDA center
Human Drugs
Project area
New Drug Evaluation
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 211.165(e)Test methods
  2. 21 CFR 211.166(a)(3)Valid stability test methods
  3. 21 CFR 211.192Written record of investigation incomplete

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Lonza Bend Inc

3
DateClassificationOfficeProject area
August 5, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 30, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 3, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Lonza Bend Inc
  • FDA Inspection 1176638 - 2022-08-05
  • FDA Inspection 1016970 - 2017-06-30
  • FDA Inspection 985218 - 2016-06-03

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