Quotient Sciences - Philadelphia, LLCAugust 16, 2022

FDA 483 - Quotient Sciences - Philadelphia, LLC - August 16, 2022

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Record Details

An FDA inspection of Quotient Sciences in Garnet Valley, PA, revealed significant deficiencies in equipment qualification and cleaning validation practices. The firm failed to properly qualify manufacturing equipment through IQ/OQ/PQ studies and did not adequately investigate cleaning verification failures or validate cleaning procedures for equipment used in drug product manufacturing.

Company: Quotient Sciences - Philadelphia, LLC
Inspection Date: August 16, 2022
Product Type: Drugs
Office: Philadelphia District Office
People: Christina K. Theodorou (Consumer Safety Officer)
Brandy N. Lepage (Consumer Safety Officer)

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ID · 8d2dd08a-44d4-4267-9356-233260aeb015