Human Genome Sciences, Inc.
FDA inspection history in Rockville, Maryland, 2013 to 2023
- 4
- Form 483s
Every document, by year
- Form 483
2013: one Form 483; 2019: one Form 483; 2020: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One Form 483, at Rockville, Maryland.
- 2013The longest 483 on file: 11 observations over 5 pages at Rockville, Maryland.
- 2019–20Two Form 483s, at Rockville, Maryland.
- 2023One Form 483, at Rockville, Maryland.
Cited most
Across all Human Genome Sciences observations on file
- 21 CFR 211.100Written procedures; deviations6
- 21 CFR 211.192Production record review4
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.25Personnel qualifications2
The complete Human Genome Sciences file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Rockville, Maryland
Four Form 483s · 2013 to 2023 · 22 observations
Latest: Form 483, Dec 11, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-11 | 483 Form 483 | Rockville, Maryland | 6 | $99 |
| 2020-01-29 | 483 Form 483 | Rockville, Maryland | 3 | $99 |
| 2019-03-15 | 483 Form 483 | Rockville, Maryland | 2 | $99 |
| 2013-04-26 | 483 Form 483 | Rockville, Maryland | 11 | $99 |
Investigators on these documents
Amy Devlin (1)Andrea Siegel (1)Anjali Shukla (1)Bo Chi (1)Brian M. Janelsins (1)Donald Obenhuber (1)Jee Y. Chung (1)Jennifer Swisher (1)Kathy Lee (1)Madushini Dharmasena (1)Nebil A. Oumer (1)Scott R. Nichols (1)
FEI number 3003782237 · most recent document Dec 11, 2023
About Human Genome Sciences, Inc.
How many FDA Form 483s has Human Genome Sciences, Inc. received?
FDA Intel has 4 Form 483s on file for Human Genome Sciences, Inc.; the most recent is dated Dec 11, 2023.
When was Human Genome Sciences, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Human Genome Sciences, Inc. is a Form 483 dated Dec 11, 2023, for the site in Rockville, Maryland.
What did FDA cite at Human Genome Sciences, Inc.?
The regulations cited most in the observations on file for Human Genome Sciences, Inc. are 21 CFR 211.100 (Written procedures; deviations), 6 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times.