Zhuhai United Laboratories Co., Ltd
Form 483 issued August 3, 2023 · Zhuhai, China
- Inspection
- Jul 27 – Aug 3, 2023
- Investigators
- Justin A. Boyd· Ones Mi Lh
- Observations
- 8
- Pages
- 7
- FEI number
- 3006531950
In short: On August 3, 2023, FDA issued a Form 483 with 8 observations to Zhuhai United Laboratories Co., Ltd in Zhuhai, Guangdong (FEI 3006531950) after an inspection that ran Jul 27 – Aug 3, 2023. The investigators were Justin A. Boyd and Ones Mi Lh. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 5 of 8 observations.
Most cited: 21 CFR 211.160 (2×) · 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Specifications and test procedures are not consistent with those included in the…
- 02
Investigation of unexpected occurrences…
- 03
Recovered solvents are not controlled and monitored to ensure that they meet appropriate standards before comingling…
- 04
Laboratory records do not include a complete record of all raw…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.160
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 laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Zhuhai United Laboratories Co., Ltd?
Justin A. Boyd and Ones Mi Lh are named on this Form 483, for the inspection of Jul 27 – Aug 3, 2023. Each investigator has a profile showing what they cite most.
When was Zhuhai United Laboratories Co., Ltd inspected by FDA?
The inspection ran Jul 27 – Aug 3, 2023, and the Form 483 is dated August 3, 2023.
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.