VA San Diego Healthcare Systems

Form 483 issued May 8, 2026 · San Diego, California

Inspection
Apr 27 – May 8, 2026
Observations
11
Pages
13
FEI number
2071629

In short: On May 8, 2026, FDA issued a Form 483 with 11 observations to VA San Diego Healthcare Systems in San Diego, California (FEI 2071629) after an inspection that ran Apr 27 – May 8, 2026. The investigators were Cecilia H. Kieu and Matthew R. Clabeaux. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).

At a glance

8 of 11 observations on this 483 concern production.

Production8
Facilities & equipment3

Most cited: 21 CFR 211.113 (8×) · 211.67 (3×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Smoke studies were inadequately…

  2. 02

    Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…

  3. 03

    Contamination was observed in…

  4. 04

    Lack of disinfection of supplies at each transition from areas of lower quality air to areas…

7 more observations

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

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at VA San Diego Healthcare Systems?

FDA listed 11 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.

Who inspected VA San Diego Healthcare Systems?

Cecilia H. Kieu and Matthew R. Clabeaux are named on this Form 483, for the inspection of Apr 27 – May 8, 2026. Each investigator has a profile showing what they cite most.

When was VA San Diego Healthcare Systems inspected by FDA?

The inspection ran Apr 27 – May 8, 2026, and the Form 483 is dated May 8, 2026.

How do I get the full Form 483 for VA San Diego Healthcare Systems?

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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