InfuTronix LLC
FDA inspection history in Natick, Massachusetts, 2022 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2022: one warning letter and one Form 483; 2023: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23One warning letter, one Form 483 and one amended 483, at Natick, Massachusetts.
- 2022The longest 483 on file: 5 observations over 6 pages at Natick, Massachusetts.
Cited most
Across all InfuTronix observations on file
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.30(g)Design controls1
The complete InfuTronix 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
Natick, Massachusetts
One amended 483, one warning letter and one Form 483 · 2022 to 2023 · 9 observations
Latest: Form 483, Aug 16, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-16 | Amended 483 Amended 483 | Natick, Massachusetts | 4 | $99 |
| 2022-06-16 | Warning letter Warning letter | Natick, Massachusetts | — | $99 |
| 2022-02-15 | 483 Form 483 | Natick, Massachusetts | 5 | $99 |
Investigators on these documents
FEI number 3011581906 · most recent document Aug 16, 2023
About InfuTronix LLC
How many FDA Form 483s has InfuTronix LLC received?
FDA Intel has 2 Form 483s on file for InfuTronix LLC; the most recent is dated Aug 16, 2023.
When was InfuTronix LLC last inspected by FDA?
The most recent FDA inspection document on file for InfuTronix LLC is a Form 483 dated Aug 16, 2023, for the site in Natick, Massachusetts.
What did FDA cite at InfuTronix LLC?
The regulations cited most in the observations on file for InfuTronix LLC are 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 820.198(a) (Complaint files), 2 times.
Has InfuTronix LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for InfuTronix LLC; the most recent is dated Jun 16, 2022.