Shire Human Genetic Therapies, Inc.
Form 483 issued March 23, 2022 · Lexington, Massachusetts
- Inspection
- Mar 19 – Mar 23, 2022
- Investigator
- Ce Sue Scott Lute
- Observations
- 4
- Pages
- 3
- FEI number
- 3009340644
In short: On March 23, 2022, FDA issued a Form 483 with 4 observations to Shire Human Genetic Therapies, Inc. in Lexington, Massachusetts (FEI 3009340644) after an inspection that ran Mar 19 – Mar 23, 2022. The investigator was Ce Sue Scott Lute. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A manufacturing batch record…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Control over an equipment…
- 04
Compressed gas utilities have…
This inspection in context
Ce Sue Scott Lute
1 document · 2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Massachusetts.
The firmShire Human Genetic Therapies, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.186
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shire Human Genetic Therapies, Inc.?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Shire Human Genetic Therapies, Inc.?
Ce Sue Scott Lute is named on this Form 483, for the inspection of Mar 19 – Mar 23, 2022. Each investigator has a profile showing what they cite most.
When was Shire Human Genetic Therapies, Inc. inspected by FDA?
The inspection ran Mar 19 – Mar 23, 2022, and the Form 483 is dated March 23, 2022.
How do I get the full Form 483 for Shire Human Genetic Therapies, 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.