483
Curia New Mexico, LLCFDA 483 - Curia New Mexico, LLC - June 28, 2024
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An FDA inspection of Curia New Mexico, LLC, a sterile drug manufacturer in Albuquerque, NM, revealed significant deficiencies in aseptic processing. Observations included unvalidated hold times for environmental monitoring samples, a lack of required testing for Grade A filling lines, and improper personnel monitoring procedures, indicating potential risks to product sterility.
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ID · 2073861b-35d0-477e-b598-529f53264a0b