Human Genome Sciences, Inc.
Form 483 issued April 26, 2013 · Rockville, Maryland
- Inspection
- Apr 16 – Apr 26, 2013
- Investigators
- Bo Chi· Donald Obenhuber· Jee Y. Chung
- Observations
- 11
- Pages
- 5
- FEI number
- 3003782237
In short: On April 26, 2013, FDA issued a Form 483 with 11 observations to Human Genome Sciences, Inc. in Rockville, Maryland (FEI 3003782237) after an inspection that ran Apr 16 – Apr 26, 2013. The investigators were Bo Chi, Donald Obenhuber, Jee Y. Chung, Kathy Lee, Nebil A. Oumer and Zhihao Peter Qiu. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and facilities & equipment account for 7 of 11 observations.
Most cited: 21 CFR 211.192 (3×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The manufacturing process is…
- 02
There is no assurance that the” step for the manufacturing process is…
- 03
There is no assurance that media and buffers used for” drug substance manufacturing are suitable…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Bo Chi
8 documents · 2013–2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Human Genome Sciences, Inc.?
FDA listed 11 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Human Genome Sciences, Inc.?
Bo Chi, Donald Obenhuber, Jee Y. Chung, Kathy Lee, Nebil A. Oumer and Zhihao Peter Qiu are named on this Form 483, for the inspection of Apr 16 – Apr 26, 2013. Each investigator has a profile showing what they cite most.
When was Human Genome Sciences, Inc. inspected by FDA?
The inspection ran Apr 16 – Apr 26, 2013, and the Form 483 is dated April 26, 2013.
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.