Ambu Limited Xiang Yu F.T. Z., No, C Warehouse & Process Complex Building
Form 483 issued October 25, 2018 · Xiamen, China
- Inspection
- Oct 22 – Oct 25, 2018
- Investigator
- Dianiris C. Ayala
- Observations
- 1
- Pages
- 4
- FEI number
- 3003924186
In short: On October 25, 2018, FDA issued a Form 483 with 1 observation to Ambu Limited Xiang Yu F.T. Z., No, C Warehouse & Process Complex Building in Xiamen, China (FEI 3003924186) after an inspection that ran Oct 22 – Oct 25, 2018. The investigator was Dianiris C. Ayala. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have not been adequately established. Your firm’s Procedure for Corrective…
This inspection in context
Dianiris C. Ayala
8 documents · 2009–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmAmbu Limited Xiang Yu F.T. Z., No, C Warehouse & Process Complex Building history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ambu Limited Xiang Yu F.T. Z., No, C Warehouse & Process Complex Building?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Ambu Limited Xiang Yu F.T. Z., No, C Warehouse & Process Complex Building?
Dianiris C. Ayala is named on this Form 483, for the inspection of Oct 22 – Oct 25, 2018. Each investigator has a profile showing what they cite most.
When was Ambu Limited Xiang Yu F.T. Z., No, C Warehouse & Process Complex Building inspected by FDA?
The inspection ran Oct 22 – Oct 25, 2018, and the Form 483 is dated October 25, 2018.
How do I get the full Form 483 for Ambu Limited Xiang Yu F.T. Z., No, C Warehouse & Process Complex Building?
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.