Shanghai STA Pharmaceutical Product Co., Ltd.
Form 483 issued June 28, 2024 · Shanghai, China
- Inspection
- Jun 24 – Jun 28, 2024
- Observations
- 3
- Pages
- 4
- FEI number
- 3014310427
In short: On June 28, 2024, 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 Jun 24 – Jun 28, 2024. Most observations concern quality system and production.
At a glance
Quality system and production 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 any unexplained discrepancy and the failure of a batch…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Written procedures are not established for the use of fumigating agents | designed to prevent the…
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, production and facilities & equipment. 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 Jun 24 – Jun 28, 2024, and the Form 483 is dated June 28, 2024.
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.