Zhuhai United Laboratories Co., Ltd
Form 483 issued September 15, 2017 · Zhuhai, China
- Observations
- 14
- Pages
- 10
- FEI number
- 3006531950
In short: On September 15, 2017, FDA issued a Form 483 with 14 observations to Zhuhai United Laboratories Co., Ltd in Zhuhai, Guangdong (FEI 3006531950). Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.160 (3×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory investigation procedures are…
- 02
Laboratory records are not…
- 03
Methods used in the testing and release of finished APIs and finished products…
- 04
Deviations from written procedures are not investigated…
This inspection in context
Questions about this 483
What did FDA find at Zhuhai United Laboratories Co., Ltd?
FDA listed 14 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Zhuhai United Laboratories Co., Ltd inspected by FDA?
This Form 483 is dated September 15, 2017.
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.