fda_483 · inspection_citation · high
Bio-Thera Solutions, Ltd. -- FDA 483: 5 observations (2025-01-17)
- Event date
- 2025-01-17 00:00:00Z
- Observed
- 2026-07-12 22:32:49Z
- Source ID
- 3017231337-2025-01-17-192338
- Payload hash
- 073acc67605edd5e45e9f725…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not fully established or followed. Specifically, A. Aseptic techniques aimed a...
Entities
Informational only. Not legal, financial, or medical advice.