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FDA Inspection
•Pascal Company Inc•August 21, 2025

Pascal Company Inc – FDA Inspection, Aug 21, 2025

Record Details

This FDA Inspection record concerns Pascal Company Inc, with an inspection on August 21, 2025, issued by the Seattle District Office, covering medical devices & rad health.

Company
Pascal Company Inc
Inspection Date
August 21, 2025
Product Type
Medical Devices & Rad Health
Office
Seattle District Office
People
  • Bryan A. Galvez (FDA Associated Person)
  • Gloria E. Andia (Issuing Officer)
View Company Profile

ID · ce532716-631d-43d7-9b93-80d6558db903

Inspection Facts

Inspection number
1281932
FDA center
Medical Devices & Rad Health
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 211.68(b)Computer control of master formula records
  2. 21 CFR 211.160(b)Scientifically sound laboratory controls
  3. 21 CFR 211.100(a)Absence of Written Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Pascal Company Inc

5
DateClassificationOfficeProject area
March 5, 2018NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
August 31, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
February 25, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
August 3, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 21, 2011NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Pascal Company Inc
  • FDA Inspection 1045499 - 2018-03-05
  • FDA Inspection 982509 - 2016-08-31
  • FDA Inspection 823613 - 2013-02-25
  • FDA Inspection 739605 - 2011-08-03
  • FDA Inspection 721969 - 2011-04-21

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