Zhejiang Meimi Technology Co., Ltd.
Form 483 issued May 17, 2024 · Yiwu, China
- Inspection
- May 13 – May 17, 2024
- Investigator
- Rowena S. Nguyen
- Observations
- 9
- Pages
- 7
- FEI number
- 3016802204
In short: On May 17, 2024, FDA issued a Form 483 with 9 observations to Zhejiang Meimi Technology Co., Ltd. in Yiwu, Zhejiang (FEI 3016802204) after an inspection that ran May 13 – May 17, 2024. The investigator was Rowena S. Nguyen. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The identity of each component of a drug product is not verified by conducting at least…
- 02
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 03
Distribution records do not contain the lot or control…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Rowena S. Nguyen
12 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in California.
The firmZhejiang Meimi Technology Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Meimi Technology Co., Ltd.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Zhejiang Meimi Technology Co., Ltd.?
Rowena S. Nguyen is named on this Form 483, for the inspection of May 13 – May 17, 2024. Each investigator has a profile showing what they cite most.
When was Zhejiang Meimi Technology Co., Ltd. inspected by FDA?
The inspection ran May 13 – May 17, 2024, and the Form 483 is dated May 17, 2024.
How do I get the full Form 483 for Zhejiang Meimi Technology 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.