FDA Intel

Gilead Sciences, Inc.

Form 483 issued February 9, 2026 · La Verne, California

Inspection
Feb 9, 2026
Investigator
Katherine C. Jacobi
Observations
7
Pages
10
FEI number
3013189568

In short: On February 9, 2026, FDA issued a Form 483 with 7 observations to Gilead Sciences, Inc. in La Verne, California (FEI 3013189568) after an inspection that ran Feb 9, 2026. The investigator was Katherine C. Jacobi. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).

At a glance

5 of 7 observations on this 483 concern laboratory controls.

Laboratory controls5
Quality system1
Production1

Most cited: 21 CFR 211.170(b) (2×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.22(d)

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

  2. 02
    21 CFR 211.160(b)

    Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…

  3. 03
    21 CFR 211.170(b)

    Reserve drug product samples are not representative of each lot or batch of drug product and…

  4. 04
    21 CFR 211.167(a)

    Test procedures relative to appropriate laboratory testing for…

3 more observations

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

Get the full 483

This inspection in context

The investigator

Katherine C. Jacobi

2 documents · 2026

Cites 211.160(a) (general requirements) more than any other section. Most of their documents are for sites in California.

The firm

Gilead Sciences, Inc. history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.170(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Gilead Sciences, Inc.?

FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.

Who inspected Gilead Sciences, Inc.?

Katherine C. Jacobi is named on this Form 483, for the inspection of Feb 9, 2026. Each investigator has a profile showing what they cite most.

When was Gilead Sciences, Inc. inspected by FDA?

The inspection ran Feb 9, 2026, and the Form 483 is dated February 9, 2026.

How do I get the full Form 483 for Gilead Sciences, Inc.?

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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