483
Gulbrandsen Technologies IncFDA 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.
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