Bio-Thera Solutions, Ltd.
Form 483 issued August 18, 2023 · Guangzhou, China
- Observations
- 2
- Pages
- 1
- FEI number
- 3017231337
In short: On August 18, 2023, FDA issued a Form 483 with 2 observations to Bio-Thera Solutions, Ltd. in Guangzhou, Guangdong (FEI 3017231337). Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Procedures for facility microbial…
This inspection in context
Questions about this 483
What did FDA find at Bio-Thera Solutions, Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
When was Bio-Thera Solutions, Ltd. inspected by FDA?
This Form 483 is dated August 18, 2023.
How do I get the full Form 483 for Bio-Thera Solutions, Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.