fda_483 · inspection_citation · high

Hikma Injectables USA Inc. -- FDA 483: 3 observations (2025-08-08)

Event date
2025-08-08 00:00:00Z
Observed
2026-07-12 22:31:59Z
Source ID
3022897129-2025-08-08-188426
Payload hash
acaf5a5dc0d57c5f3a270142

Summary

Observation 2: Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of ...

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