Alliance Medical Products, Inc. (dba Siegfried Irvine)
Form 483 issued February 14, 2019 · Irvine, California
- Inspection
- Feb 5 – Feb 14, 2019
- Observations
- 8
- Pages
- 26
- FEI number
- 2027189
In short: On February 14, 2019, FDA issued a Form 483 with 8 observations to Alliance Medical Products, Inc. (dba Siegfried Irvine) in Irvine, California (FEI 2027189) after an inspection that ran Feb 5 – Feb 14, 2019. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Laboratory controls and quality system account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Questions about this 483
What did FDA find at Alliance Medical Products, Inc. (dba Siegfried Irvine)?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Alliance Medical Products, Inc. (dba Siegfried Irvine) inspected by FDA?
The inspection ran Feb 5 – Feb 14, 2019, and the Form 483 is dated February 14, 2019.
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.