ScinoPharm Taiwan, Ltd.
Form 483 issued April 1, 2022 · Tainan, Taiwan
- Inspection
- Mar 21 – Apr 1, 2022
- Observations
- 2
- Pages
- 2
- FEI number
- 3002840477
In short: On April 1, 2022, FDA issued a Form 483 with 2 observations to ScinoPharm Taiwan, Ltd. in Tainan, Taiwan (FEI 3002840477) after an inspection that ran Mar 21 – Apr 1, 2022. Most observations concern materials; the most-cited regulation is 21 CFR 211.86 (use of approved components, drug product containers, and closures).
At a glance
Observations span 1 system, led by materials.
Most cited: 21 CFR 211.86 (1×)
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 lack of rotation so that the oldest approved stock of…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Questions about this 483
What did FDA find at ScinoPharm Taiwan, Ltd.?
FDA listed 2 observations on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.86 (use of approved components, drug product containers, and closures). The opening words of each observation are shown on this page.
When was ScinoPharm Taiwan, Ltd. inspected by FDA?
The inspection ran Mar 21 – Apr 1, 2022, and the Form 483 is dated April 1, 2022.
How do I get the full Form 483 for ScinoPharm Taiwan, 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.