fda_483 · inspection_citation · high

Exela Pharma Sciences LLC -- FDA 483: 15 observations (2024-11-15)

Event date
2024-11-15 00:00:00Z
Observed
2026-07-12 22:32:55Z
Source ID
3008563008-2024-11-15-185443
Payload hash
26d213a549fdc9e7a9d31ee4

Summary

Observation 1: Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. Specifically, 503B Outsourcing facility A. L,,_____________ (b) (4)...

Informational only. Not legal, financial, or medical advice.