Paragon Swiss
Form 483 issued January 12, 2024 · Santa Clara, California
- Investigator
- Saied A. Asbagh
- Observations
- 3
- Pages
- 4
- FEI number
- 3026501935
In short: On January 12, 2024, FDA issued a Form 483 with 3 observations to Paragon Swiss in Santa Clara, California (FEI 3026501935). The investigator was Saied A. Asbagh. Most observations concern quality system.
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
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Employees are not given training in the particular operations they perform as part of their function…
- 03
Results of stability testing are not used in determining appropriate storage…
This inspection in context
Saied A. Asbagh
12 documents · 2016–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmParagon Swiss history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Paragon Swiss?
FDA listed 3 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.
Who inspected Paragon Swiss?
Saied A. Asbagh is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Paragon Swiss inspected by FDA?
This Form 483 is dated January 12, 2024.
How do I get the full Form 483 for Paragon Swiss?
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.