Ming Fai Industrial (Shenzhen) Co., Ltd.
Form 483 issued August 11, 2017 · Shenzhen, China
- Inspection
- Aug 11, 2017
- Observations
- 6
- Pages
- 4
- FEI number
- 3003340745
In short: On August 11, 2017, 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 Aug 11, 2017. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 4 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
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Drug product production and control records, are not reviewed by the quality control unit to determine…
- 04
Employees are not given training in the particular operations they perform as…
This inspection in context
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 laboratory controls, quality system and production. The opening words of each observation are shown on this page.
When was Ming Fai Industrial (Shenzhen) Co., Ltd. inspected by FDA?
The inspection ran Aug 11, 2017, and the Form 483 is dated August 11, 2017.
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.