Zhejiang Ruibang Laboratories
Form 483 issued July 21, 2016 · Wenzhou, China
- Observations
- 3
- Pages
- 2
- FEI number
- 3001027745
In short: On July 21, 2016, FDA issued a Form 483 with 3 observations to Zhejiang Ruibang Laboratories in Wenzhou, Zhejiang (FEI 3001027745). Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Computerized systems shall have sufficient controls to prevent unauthorized access or changes to data, There shall…
- 02
Written procedures should describe the sampling methods for in-process materials, intermediates, and APIs. Sampling Plans and…
- 03
Any deviation should be documented and explained, Any critical…
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 facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
When was Zhejiang Ruibang Laboratories inspected by FDA?
This Form 483 is dated July 21, 2016.
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.