Shanghai Desano Bio-Pharmaceutical Co., Ltd.
Form 483 issued August 2, 2019 · Shanghai, China
- Investigator
- Hongna Wang
- Observations
- 4
- Pages
- 3
- FEI number
- 3008345655
In short: On August 2, 2019, FDA issued a Form 483 with 4 observations to Shanghai Desano Bio-Pharmaceutical Co., Ltd. in Shanghai, China (FEI 3008345655). The investigator was Hongna Wang. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Hongna Wang
1 document · 2019
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in China.
The firmShanghai Desano Bio-Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shanghai Desano Bio-Pharmaceutical Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Shanghai Desano Bio-Pharmaceutical Co., Ltd.?
Hongna Wang is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Shanghai Desano Bio-Pharmaceutical Co., Ltd. inspected by FDA?
This Form 483 is dated August 2, 2019.
How do I get the full Form 483 for Shanghai Desano Bio-Pharmaceutical 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.