Seqirus Inc
FDA inspection history in Holly Springs, North Carolina, 2016 to 2022
- 3
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2018: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Two Form 483s, at Holly Springs, North Carolina.
- 2016The longest 483 on file: 4 observations over 3 pages at Holly Springs, North Carolina.
- 2022One Form 483, at Holly Springs, North Carolina.
Cited most
Across all Seqirus observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Seqirus file.
All 3 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
Holly Springs, North Carolina
Three Form 483s · 2016 to 2022 · 4 observations
Latest: Form 483, Jun 9, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-06-09 | 483 Form 483 | Holly Springs, North Carolina | — | $99 |
| 2018-06-18 | 483 Form 483 | Holly Springs, North Carolina | — | $99 |
| 2016-05-17 | 483 Form 483 | Holly Springs, North Carolina | 4 | $99 |
Investigators on these documents
Gene Arey (1)Haruhiko Murata (1)Jean Hu-Primmer (1)Nw W. Keller (1)
FEI number 3007867647 · most recent document Jun 9, 2022
About Seqirus Inc
How many FDA Form 483s has Seqirus Inc received?
FDA Intel has 3 Form 483s on file for Seqirus Inc; the most recent is dated Jun 9, 2022.
When was Seqirus Inc last inspected by FDA?
The most recent FDA inspection document on file for Seqirus Inc is a Form 483 dated Jun 9, 2022, for the site in Holly Springs, North Carolina.
What did FDA cite at Seqirus Inc?
The regulations cited most in the observations on file for Seqirus Inc are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.