Hainan Shuangcheng Pharmaceuticals Co., Ltd.
Form 483 issued April 24, 2019 · Haikou City, China
- Inspection
- Apr 24, 2019
- Investigator
- Jonathan W. Chapman
- Observations
- 4
- Pages
- 3
- FEI number
- 3009010397
In short: On April 24, 2019, FDA issued a Form 483 with 4 observations to Hainan Shuangcheng Pharmaceuticals Co., Ltd. in Haikou City, Hainan Province (FEI 3009010397) after an inspection that ran Apr 24, 2019. The investigator was Jonathan W. Chapman. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system 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
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Employees engaged in the manufacture of a drug product lack the training required to perform…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Jonathan W. Chapman
11 documents · 2014–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmHainan Shuangcheng Pharmaceuticals Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hainan Shuangcheng Pharmaceuticals Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Hainan Shuangcheng Pharmaceuticals Co., Ltd.?
Jonathan W. Chapman is named on this Form 483, for the inspection of Apr 24, 2019. Each investigator has a profile showing what they cite most.
When was Hainan Shuangcheng Pharmaceuticals Co., Ltd. inspected by FDA?
The inspection ran Apr 24, 2019, and the Form 483 is dated April 24, 2019.
How do I get the full Form 483 for Hainan Shuangcheng Pharmaceuticals 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.