Zhejiang Ruibang Laboratories
Form 483 issued October 25, 2024 · Wenzhou, China
- Observations
- 3
- Pages
- 2
- FEI number
- 3001027745
In short: On October 25, 2024, FDA issued a Form 483 with 3 observations to Zhejiang Ruibang Laboratories in Wenzhou, Zhejiang (FEI 3001027745). Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 3 observations.
Most cited: 21 CFR 211.192 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to fully investigate any unexplained discrepancy whether or not…
- 02
The accuracy of test methods…
- 04
INo written procedures to control, describe in detail and/or explain the production…
This inspection in context
Questions about this 483
What did FDA find at Zhejiang Ruibang Laboratories?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Zhejiang Ruibang Laboratories inspected by FDA?
This Form 483 is dated October 25, 2024.
How do I get the full Form 483 for Zhejiang Ruibang Laboratories?
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.