Zhuhai United Laboratories Co., Ltd
Form 483 issued March 31, 2015 · Zhuhai, China
- Inspection
- Mar 23 – Mar 31, 2015
- Investigator
- Ied Muiz
- Observations
- 11
- Pages
- 9
- FEI number
- 3006531950
In short: On March 31, 2015, FDA issued a Form 483 with 11 observations to Zhuhai United Laboratories Co., Ltd in Zhuhai, Guangdong (FEI 3006531950) after an inspection that ran Mar 23 – Mar 31, 2015. The investigator was Ied Muiz. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 8 of 11 observations.
Most cited: 21 CFR 211.113 (4×) · 211.42 (2×)
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
Observation 2: scanned text, readable in the full document.
- 03
The following pertains to the (b) (4) Technology (b) (4) RABs) that is used to aseptically…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Ied Muiz
1 document · 2015
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in China.
The firmZhuhai United Laboratories Co., Ltd history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhuhai United Laboratories Co., Ltd?
FDA listed 11 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Zhuhai United Laboratories Co., Ltd?
Ied Muiz is named on this Form 483, for the inspection of Mar 23 – Mar 31, 2015. Each investigator has a profile showing what they cite most.
When was Zhuhai United Laboratories Co., Ltd inspected by FDA?
The inspection ran Mar 23 – Mar 31, 2015, and the Form 483 is dated March 31, 2015.
How do I get the full Form 483 for Zhuhai United Laboratories Co., 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.