Human Genome Sciences, Inc.
Form 483 issued March 15, 2019 · Rockville, Maryland
- Inspection
- Mar 15, 2019
- Investigators
- Andrea Siegel· Jennifer Swisher· Madushini Dharmasena
- Observations
- 2
- Pages
- 1
- FEI number
- 3003782237
In short: On March 15, 2019, FDA issued a Form 483 with 2 observations to Human Genome Sciences, Inc. in Rockville, Maryland (FEI 3003782237) after an inspection that ran Mar 15, 2019. The investigators were Andrea Siegel, Jennifer Swisher, Madushini Dharmasena, Scott R. Nichols and Shadia Zaman. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a lack of quality oversight in the review of records and procedures followed in…
- 02
Written procedures are not followed during manufacturing operations…
This inspection in context
Andrea Siegel
2 documents · 2019–2020
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmHuman Genome Sciences, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Human Genome Sciences, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Human Genome Sciences, Inc.?
Andrea Siegel, Jennifer Swisher, Madushini Dharmasena, Scott R. Nichols and Shadia Zaman are named on this Form 483, for the inspection of Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Human Genome Sciences, Inc. inspected by FDA?
The inspection ran Mar 15, 2019, and the Form 483 is dated March 15, 2019.
How do I get the full Form 483 for Human Genome 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.