SCI Pharmtech, Inc.
Form 483 issued June 6, 2025 · Taoyuan City, Taiwan
- Inspection
- Jun 2 – Jun 6, 2025
- Investigator
- Nicholas J. Presto
- Observations
- 1
- Pages
- 1
- FEI number
- 3004065859
In short: On June 6, 2025, FDA issued a Form 483 with 1 observation to SCI Pharmtech, Inc. in Taoyuan City, Taiwan (FEI 3004065859) after an inspection that ran Jun 2 – Jun 6, 2025. The investigator was Nicholas J. Presto.
What FDA observed
Preview: the opening words of each observation- 01
Your batch production records do not include a representative label of APIs or commercially produced intermediates…
This inspection in context
Nicholas J. Presto
10 documents · 2023–2026
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in Michigan.
The firmSCI Pharmtech, Inc. history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at SCI Pharmtech, Inc.?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected SCI Pharmtech, Inc.?
Nicholas J. Presto is named on this Form 483, for the inspection of Jun 2 – Jun 6, 2025. Each investigator has a profile showing what they cite most.
When was SCI Pharmtech, Inc. inspected by FDA?
The inspection ran Jun 2 – Jun 6, 2025, and the Form 483 is dated June 6, 2025.
How do I get the full Form 483 for SCI Pharmtech, Inc.?
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.