Shire Human Genetic Therapies, Inc.
FDA inspection history in Lexington, Massachusetts, 2022
- 2
- Form 483s
Every document, by year
- Form 483
2022: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2022Two Form 483s, at Lexington, Massachusetts.
- 2022The longest 483 on file: 1 observation over 2 pages at Lexington, Massachusetts.
Cited most
Across all Shire Human Genetic Therapies observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.186Master production and control records1
The complete Shire Human Genetic Therapies file.
All 2 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
Lexington, Massachusetts
Two Form 483s · 2022 · 1 observation
Latest: Form 483, Apr 22, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-04-22 | 483 Form 483 | Lexington, Massachusetts | 1 | $99 |
| 2022-03-23 | 483 Form 483 | Lexington, Massachusetts | — | $99 |
Investigators on these documents
FEI number 3009340644 · most recent document Apr 22, 2022
About Shire Human Genetic Therapies, Inc.
How many FDA Form 483s has Shire Human Genetic Therapies, Inc. received?
FDA Intel has 2 Form 483s on file for Shire Human Genetic Therapies, Inc.; the most recent is dated Apr 22, 2022.
When was Shire Human Genetic Therapies, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Shire Human Genetic Therapies, Inc. is a Form 483 dated Apr 22, 2022, for the site in Lexington, Massachusetts.
What did FDA cite at Shire Human Genetic Therapies, Inc.?
The regulations cited most in the observations on file for Shire Human Genetic Therapies, Inc. are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.