Gilead Sciences Inc.
Form 483 issued February 12, 2010 · San Dimas, California
- Inspection
- Jan 25 – Feb 12, 2010
- Investigator
- Carla J. Lundi
- Observations
- 10
- Pages
- 6
- FEI number
- 2082946
In short: On February 12, 2010, FDA issued a Form 483 with 10 observations to Gilead Sciences Inc. in San Dimas, California (FEI 2082946) after an inspection that ran Jan 25 – Feb 12, 2010. The investigator was Carla J. Lundi. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 10 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
This inspection in context
Carla J. Lundi
9 documents · 2009–2021
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmGilead Sciences Inc. history
All 2 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 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Gilead Sciences Inc.?
Carla J. Lundi is named on this Form 483, for the inspection of Jan 25 – Feb 12, 2010. Each investigator has a profile showing what they cite most.
When was Gilead Sciences Inc. inspected by FDA?
The inspection ran Jan 25 – Feb 12, 2010, and the Form 483 is dated February 12, 2010.
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.