Pharmalogic Salt Lake City, LLC

Form 483 issued February 24, 2026 · Utah

Inspection
Feb 19 – Feb 24, 2026
Observations
1
Pages
3
FEI number
3029497444

In short: On February 24, 2026, FDA issued a Form 483 with 1 observation to Pharmalogic Salt Lake City, LLC in Utah (FEI 3029497444) after an inspection that ran Feb 19 – Feb 24, 2026. The investigators were Joey V. Quitania, Lillian S. Wu and Matthew R. Clabeaux. The most-cited regulation is 21 CFR 212.71 (what actions must I take if a batch of PET drug product does not conform to specifications?).

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 212.71(c)

    You did not take appropriate action to correct any identified problems to prevent recurrence of a…

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Questions about this 483

What did FDA find at Pharmalogic Salt Lake City, LLC?

FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 212.71 (what actions must I take if a batch of PET drug product does not conform to specifications?). The opening words of each observation are shown on this page.

Who inspected Pharmalogic Salt Lake City, LLC?

Joey V. Quitania, Lillian S. Wu and Matthew R. Clabeaux are named on this Form 483, for the inspection of Feb 19 – Feb 24, 2026. Each investigator has a profile showing what they cite most.

When was Pharmalogic Salt Lake City, LLC inspected by FDA?

The inspection ran Feb 19 – Feb 24, 2026, and the Form 483 is dated February 24, 2026.

How do I get the full Form 483 for Pharmalogic Salt Lake City, LLC?

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