Aurolife Pharma, LLC – FDA 483, Dec 7, 2021
An FDA inspection of AuroLife Pharma, LLC in Dayton, NJ, revealed significant deficiencies in data integrity, quality control unit procedures, and facility maintenance, including persistent water leaks. The inspection also cited inadequate laboratory controls, unvalidated test methods, and insufficient equipment cleaning protocols, indicating a broad failure to adhere to cGMP regulations. Several observations were repeats from a previous 483, highlighting a lack of effective corrective actions.
ID · c6b0115c-7a88-4138-8337-6f7454a491c3
- WARNING_LETTER - 2020-02-12
- 483 - 2020-02-12
- 483 - 2019-10-22
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.