Ming Fai Industrial (Shenzhen) Co., Ltd.
Form 483 issued March 10, 2023 · Shenzhen, China
- Inspection
- Mar 6 – Mar 10, 2023
- Investigator
- Janete F. Guardia
- Observations
- 6
- Pages
- 5
- FEI number
- 3003340745
In short: On March 10, 2023, FDA issued a Form 483 with 6 observations to Ming Fai Industrial (Shenzhen) Co., Ltd. in Shenzhen, Guangdong (FEI 3003340745) after an inspection that ran Mar 6 – Mar 10, 2023. The investigator was Janete F. Guardia. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for receiving, reviewing and evaluating complaints by a formally designated unit…
- 02
Written Medical Device Reporting procedure(s) have not been…
- 03
Process validation activities and results have not been adequately…
- 04
Document control procedures have…
This inspection in context
Janete F. Guardia
4 documents · 2016–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmMing Fai Industrial (Shenzhen) Co., Ltd. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ming Fai Industrial (Shenzhen) Co., Ltd.?
FDA listed 6 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected Ming Fai Industrial (Shenzhen) Co., Ltd.?
Janete F. Guardia is named on this Form 483, for the inspection of Mar 6 – Mar 10, 2023. Each investigator has a profile showing what they cite most.
When was Ming Fai Industrial (Shenzhen) Co., Ltd. inspected by FDA?
The inspection ran Mar 6 – Mar 10, 2023, and the Form 483 is dated March 10, 2023.
How do I get the full Form 483 for Ming Fai Industrial (Shenzhen) 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.