Infusion Partners
FDA inspection history across 2 sites, 2014 to 2022
- 2
- Form 483s
- 1
- Close-out
- 1
- Response
Every document, by year
- Close-out
- Form 483
- Response
2014: one Form 483; 2015: one 483 response; 2018: one Form 483; 2022: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–15One Form 483 and one 483 response, at Sharpsburg, Pennsylvania.
- 2014The longest 483 on file: 5 observations over 4 pages at Sharpsburg, Pennsylvania.
- 2018One Form 483, at Sharpsburg, Pennsylvania.
- 2022One close-out letter, at Canfield, Ohio.
Cited most
Across all Infusion Partners observations on file
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.28Personnel responsibilities2
The complete Infusion Partners file.
All 4 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
Sharpsburg, Pennsylvania
Two Form 483s and one 483 response · 2014 to 2018 · 7 observations
Latest: Form 483, Sep 25, 2018 →Canfield, Ohio
One close-out letter · 2022
Latest: Close-out, Jan 26, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-01-26 | Close-out Close-out letter | Canfield, Ohio | — | $99 |
| 2018-09-25 | 483 Form 483 | Sharpsburg, Pennsylvania | 2 | $99 |
| 2015-01-09 | Response 483 response | Sharpsburg, Pennsylvania | — | $199 |
| 2014-12-05 | 483 Form 483 | Sharpsburg, Pennsylvania | 5 | $99 |
Investigators on these documents
FEI number 3011127887 · most recent document Jan 26, 2022
About Infusion Partners
How many FDA Form 483s has Infusion Partners received?
FDA Intel has 2 Form 483s on file for Infusion Partners; the most recent is dated Sep 25, 2018.
When was Infusion Partners last inspected by FDA?
The most recent FDA inspection document on file for Infusion Partners is a Form 483 dated Sep 25, 2018, for the site in Sharpsburg, Pennsylvania.
What did FDA cite at Infusion Partners?
The regulations cited most in the observations on file for Infusion Partners are 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.28 (Personnel responsibilities), 2 times.