Zhuhai United Laboratories Co., Ltd
Form 483 issued July 16, 2019 · Zhuhai, China
- Inspection
- Sep 21, 2018 – Jul 16, 2019
- Investigators
- Raquel Gonzalez· Rumany C. Penn· Vincent Thomas
- Observations
- 8
- Pages
- 5
- FEI number
- 3006531950
In short: On July 16, 2019, FDA issued a Form 483 with 8 observations to Zhuhai United Laboratories Co., Ltd in Zhuhai, Guangdong (FEI 3006531950) after an inspection that ran Sep 21, 2018 – Jul 16, 2019. The investigators were Raquel Gonzalez, Rumany C. Penn and Vincent Thomas. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 5 of 8 observations.
Most cited: 21 CFR 211.192 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to properly investigate and document unexplained discrepancies or out of specification results…
- 02
(REPEAT) The invalidation of laboratory out of specification (OOS) results are not supported…
- 03
Documents are not appropriately controlled and secured against…
- 04
(REPEAT) Laboratory and raw data records…
This inspection in context
Raquel Gonzalez
2 documents · 2010–2019
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 211.192
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 8 observations on this Form 483, mostly about quality system, laboratory controls 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.
Who inspected Zhuhai United Laboratories Co., Ltd?
Raquel Gonzalez, Rumany C. Penn and Vincent Thomas are named on this Form 483, for the inspection of Sep 21, 2018 – Jul 16, 2019. Each investigator has a profile showing what they cite most.
When was Zhuhai United Laboratories Co., Ltd inspected by FDA?
The inspection ran Sep 21, 2018 – Jul 16, 2019, and the Form 483 is dated July 16, 2019.
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.