483
Pharmalogic Puerto Rico IncPharmalogic Puerto Rico Inc – FDA 483, Jul 22, 2016
Record Details
An FDA inspection of Lantheus MI Radipharmaceuticals Inc. in San Juan, PR, revealed a significant issue regarding the conditional release of PET drug products. The firm approved batches despite analytical equipment malfunctions without documenting efforts to prevent recurrence. This indicates a lapse in quality control and documentation practices.
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ID · 8007b96c-1095-4562-b32a-feef19e58ae5
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