Human Genome Sciences, Inc.
Form 483 issued December 11, 2023 · Rockville, Maryland
- Inspection
- Dec 1 – Dec 11, 2023
- Investigators
- Brian M. Janelsins· Teegan A. Dellibovi-Ragheb· Wendy G. Tan
- Observations
- 6
- Pages
- 5
- FEI number
- 3003782237
In short: On December 11, 2023, FDA issued a Form 483 with 6 observations to Human Genome Sciences, Inc. in Rockville, Maryland (FEI 3003782237) after an inspection that ran Dec 1 – Dec 11, 2023. The investigators were Brian M. Janelsins, Teegan A. Dellibovi-Ragheb and Wendy G. Tan. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Microbial control procedures for drug substance…
- 02
Root cause analysis and CAPA implementation as…
- 03
Written procedures to ensure maintenance of data integrity and product quality are inadequate…
- 04
Training procedures are inadequate…
This inspection in context
Brian M. Janelsins
2 documents · 2023
Cites 211.100 (written procedures; deviations) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Human Genome Sciences, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, quality system and materials. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Human Genome Sciences, Inc.?
Brian M. Janelsins, Teegan A. Dellibovi-Ragheb and Wendy G. Tan are named on this Form 483, for the inspection of Dec 1 – Dec 11, 2023. Each investigator has a profile showing what they cite most.
When was Human Genome Sciences, Inc. inspected by FDA?
The inspection ran Dec 1 – Dec 11, 2023, and the Form 483 is dated December 11, 2023.
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.