Alliance Medical Products, Inc. (dba Siegfried Irvine)
Form 483 issued May 26, 2017 · Irvine, California
- Inspection
- Apr 24 – May 26, 2017
- Investigators
- Amanda L. Fyles· Evelyn Wong· Linda Thai
- Observations
- 10
- Pages
- 8
- FEI number
- 2027189
In short: On May 26, 2017, FDA issued a Form 483 with 10 observations to Alliance Medical Products, Inc. (dba Siegfried Irvine) in Irvine, California (FEI 2027189) after an inspection that ran Apr 24 – May 26, 2017. The investigators were Amanda L. Fyles, Evelyn Wong, Linda Thai and Yasamin Ameri. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 7 of 10 observations.
Most cited: 21 CFR 211.165 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, specificity and reproducibility of test methods…
- 02
Input to and output from the computer and records or data are…
- 03
Written records of investigations into do not include…
- 04
Routine calibration and checking of electronic equipment is not performed according to a written program designed…
This inspection in context
Amanda L. Fyles
5 documents · 2017–2019
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in California.
The firmAlliance Medical Products, Inc. (dba Siegfried Irvine) history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alliance Medical Products, Inc. (dba Siegfried Irvine)?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Alliance Medical Products, Inc. (dba Siegfried Irvine)?
Amanda L. Fyles, Evelyn Wong, Linda Thai and Yasamin Ameri are named on this Form 483, for the inspection of Apr 24 – May 26, 2017. Each investigator has a profile showing what they cite most.
When was Alliance Medical Products, Inc. (dba Siegfried Irvine) inspected by FDA?
The inspection ran Apr 24 – May 26, 2017, and the Form 483 is dated May 26, 2017.
How do I get the full Form 483 for Alliance Medical Products, Inc. (dba Siegfried Irvine)?
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.