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483
•Gulbrandsen Technologies Inc•February 16, 2022

FDA 483 - Gulbrandsen Technologies Inc - February 16, 2022

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Record Details

Gulbrandsen Technologies Inc. in Orangeburg, SC, an API manufacturer, received a Form 483 with three observations. The inspection revealed a lack of written procedures for equipment cleaning and maintenance, deficiencies in laboratory notebook record-keeping, and inadequate controls to ensure the originality and integrity of release testing data.

Company
Gulbrandsen Technologies Inc
Inspection Date
February 16, 2022
Product Type
Drugs
Office
Atlanta District Office
Person
  • Bryan L. Mcguckin
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ID · 6a409285-53e8-438d-9ce8-679f930bc141

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