Taizhou Kangping Medical Science And Technology Co., Ltd.
Form 483 issued March 7, 2019 · Taizhou City, China
- Inspection
- Mar 4 – Mar 7, 2019
- Observations
- 3
- Pages
- 3
- FEI number
- 3013321339
In short: On March 7, 2019, FDA issued a Form 483 with 3 observations to Taizhou Kangping Medical Science And Technology Co., Ltd. in Taizhou City, Jiangsu (FEI 3013321339) after an inspection that ran Mar 4 – Mar 7, 2019. Most observations concern quality system and packaging & labeling.
At a glance
Quality system and packaging & labeling account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
The drug product is not identified with a lot or control number that permits the determination…
- 03
The master production and control records are deficient in that they do not include…
This inspection in context
Questions about this 483
What did FDA find at Taizhou Kangping Medical Science And Technology Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about quality system, packaging & labeling and production. The opening words of each observation are shown on this page.
When was Taizhou Kangping Medical Science And Technology Co., Ltd. inspected by FDA?
The inspection ran Mar 4 – Mar 7, 2019, and the Form 483 is dated March 7, 2019.
How do I get the full Form 483 for Taizhou Kangping Medical Science And 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.