Gilead Sciences, Inc.
Form 483 issued December 17, 2021 · La Verne, California
- Inspection
- Dec 6 – Dec 17, 2021
- Investigators
- Dogbeda F. Mackenzie· Jacob G. Lutz
- Observations
- 4
- Pages
- 7
- FEI number
- 3013189568
In short: On December 17, 2021, FDA issued a Form 483 with 4 observations to Gilead Sciences, Inc. in La Verne, California (FEI 3013189568) after an inspection that ran Dec 6 – Dec 17, 2021. The investigators were Dogbeda F. Mackenzie and Jacob G. Lutz. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 04
Buildings used in the of a drug product are not maintained in a…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmGilead Sciences, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gilead Sciences, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Gilead Sciences, Inc.?
Dogbeda F. Mackenzie and Jacob G. Lutz are named on this Form 483, for the inspection of Dec 6 – Dec 17, 2021. Each investigator has a profile showing what they cite most.
When was Gilead Sciences, Inc. inspected by FDA?
The inspection ran Dec 6 – Dec 17, 2021, and the Form 483 is dated December 17, 2021.
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.