Shanghai STA Pharmaceutical Product Co., Ltd.
Form 483 issued October 22, 2021 · Shanghai, China
- Inspection
- Oct 18 – Oct 22, 2021
- Observations
- 3
- Pages
- 2
- FEI number
- 3014310427
In short: On October 22, 2021, FDA issued a Form 483 with 3 observations to Shanghai STA Pharmaceutical Product Co., Ltd. in Shanghai, China (FEI 3014310427) after an inspection that ran Oct 18 – Oct 22, 2021. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records are not kept for…
- 02
Each container of components dispensed to manufacturing is not examined by a second person to assure…
- 03
Written records are not…
This inspection in context
Questions about this 483
What did FDA find at Shanghai STA Pharmaceutical Product Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
When was Shanghai STA Pharmaceutical Product Co., Ltd. inspected by FDA?
The inspection ran Oct 18 – Oct 22, 2021, and the Form 483 is dated October 22, 2021.
How do I get the full Form 483 for Shanghai STA Pharmaceutical Product 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.