483
Primera Analytical Solutions Corp.Primera Analytical Solutions Corp. – FDA 483, Nov 20, 2018
Record Details
Primera Analytical Solutions Corp., a control testing laboratory in Cranbury, NJ, was cited for four observations related to quality system deficiencies. The inspection revealed failures in thoroughly investigating out-of-specification results, inadequate protection of electronic data from deletion, unvalidated test method calculations, and the use of unapproved documents for analytical work.
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ID · 04189749-55ce-49a3-b72f-a904e1f30816
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