Changzhou Maokang Medical Products Co., Ltd
Form 483 issued August 24, 2018 · Changzhou, China
- Inspection
- Aug 20 – Aug 24, 2018
- Investigator
- Seereverse Niketa Patel
- Observations
- 2
- Pages
- 4
- FEI number
- 3010623099
In short: On August 24, 2018, FDA issued a Form 483 with 2 observations to Changzhou Maokang Medical Products Co., Ltd in Changzhou, Jiangsu (FEI 3010623099) after an inspection that ran Aug 20 – Aug 24, 2018. The investigator was Seereverse Niketa Patel. Most observations concern laboratory controls.
At a glance
2 of 2 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Seereverse Niketa Patel
1 document · 2018
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmChangzhou Maokang Medical Products Co., Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Changzhou Maokang Medical Products Co., Ltd?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The opening words of each observation are shown on this page.
Who inspected Changzhou Maokang Medical Products Co., Ltd?
Seereverse Niketa Patel is named on this Form 483, for the inspection of Aug 20 – Aug 24, 2018. Each investigator has a profile showing what they cite most.
When was Changzhou Maokang Medical Products Co., Ltd inspected by FDA?
The inspection ran Aug 20 – Aug 24, 2018, and the Form 483 is dated August 24, 2018.
How do I get the full Form 483 for Changzhou Maokang Medical Products 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.