Shire Human Genetic Therapies, Inc.
Form 483 issued April 22, 2022 · Lexington, Massachusetts
- Inspection
- Mar 29 – Apr 22, 2022
- Investigator
- Robert T. Mraz
- Observations
- 1
- Pages
- 2
- FEI number
- 3009340644
In short: On April 22, 2022, FDA issued a Form 483 with 1 observation to Shire Human Genetic Therapies, Inc. in Lexington, Massachusetts (FEI 3009340644) after an inspection that ran Mar 29 – Apr 22, 2022. The investigator was Robert T. Mraz. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Quality Unit failed to adequately assess the impact of (b)(4) Chromatography Systems (HPLC & HPLC-(b)(4))…
This inspection in context
Robert T. Mraz
1 document · 2022
Cites 211.160 (general requirements) 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 211.160
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 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Shire Human Genetic Therapies, Inc.?
Robert T. Mraz is named on this Form 483, for the inspection of Mar 29 – Apr 22, 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 29 – Apr 22, 2022, and the Form 483 is dated April 22, 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.