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483
•Brooks Life Sciences Inc•July 6, 2018

FDA 483 - Brooks Life Sciences Inc - July 06, 2018

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Record Details

An FDA inspection of BioStorage Technologies in Indianapolis, IN, an HCT/P establishment, identified one observation. The firm failed to maintain equipment used for manufacturing HCT/Ps according to established schedules. Specifically, a cryogenic freezer used for human tissue storage was not maintained per the manufacturer's manual.

Company
Brooks Life Sciences Inc
Inspection Date
July 6, 2018
Product Type
Biologics
Office
Division of Pharmaceutical Quality Operations III
Person
  • Lewis K. Antwi
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ID · c1cdacf8-84cb-4cda-b895-5580225d12b2

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