483
Quotient Sciences - Philadelphia, LLCQuotient Sciences - Philadelphia, LLC – FDA 483, Aug 16, 2022
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.
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ID · 8d2dd08a-44d4-4267-9356-233260aeb015
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