Human Genome Sciences, Inc.
Form 483 issued January 29, 2020 · Rockville, Maryland
- Inspection
- Jan 22 – Jan 29, 2020
- Investigators
- Amy Devlin· Anjali Shukla· Thuy T. Nguyen
- Observations
- 3
- Pages
- 2
- FEI number
- 3003782237
In short: On January 29, 2020, FDA issued a Form 483 with 3 observations to Human Genome Sciences, Inc. in Rockville, Maryland (FEI 3003782237) after an inspection that ran Jan 22 – Jan 29, 2020. The investigators were Amy Devlin, Anjali Shukla, Thuy T. Nguyen and Xiaoshi Wang. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The nanufacturing process is…
- 02
Written procedures were not…
- 03
Training procedures are not…
This inspection in context
Amy Devlin
4 documents · 2019–2020
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Illinois.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Human Genome Sciences, Inc.?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Human Genome Sciences, Inc.?
Amy Devlin, Anjali Shukla, Thuy T. Nguyen and Xiaoshi Wang are named on this Form 483, for the inspection of Jan 22 – Jan 29, 2020. Each investigator has a profile showing what they cite most.
When was Human Genome Sciences, Inc. inspected by FDA?
The inspection ran Jan 22 – Jan 29, 2020, and the Form 483 is dated January 29, 2020.
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.