FDA Intel

Alliance Medical Products, Inc. (dba Siegfried Irvine)

Form 483 issued May 21, 2021 · Irvine, California

Inspection
May 10 – May 21, 2021
Investigators
Bryan A. Galvez· Joel D. Hustedt
Observations
4
Pages
6
FEI number
2027189

In short: On May 21, 2021, FDA issued a Form 483 with 4 observations to Alliance Medical Products, Inc. (dba Siegfried Irvine) in Irvine, California (FEI 2027189) after an inspection that ran May 10 – May 21, 2021. The investigators were Bryan A. Galvez and Joel D. Hustedt. Most observations concern facilities & equipment and quality system.

At a glance

Facilities & equipment and quality system account for 4 of 4 observations.

Facilities & equipment2
Quality system2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.68(a)

    Records of the mspections of automatic, mechanical or electronic equipment, includmg computers or related…

  2. 02
    21 CFR 211.22(d)

    The responsibilities and procedures applicable to the quality control unit are not in…

  3. 03
    21 CFR 211.192

    There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…

  4. 04
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Bryan A. Galvez

15 documents · 2018–2026

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.

The firm

Alliance 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 483s

Other sites cited under 211.68(a)

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 4 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.

Who inspected Alliance Medical Products, Inc. (dba Siegfried Irvine)?

Bryan A. Galvez and Joel D. Hustedt are named on this Form 483, for the inspection of May 10 – May 21, 2021. 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 May 10 – May 21, 2021, and the Form 483 is dated May 21, 2021.

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.

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