FEI 3017580485
FDA inspection history in Amherst, Massachusetts, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Amherst, Massachusetts.
Cited most
Across all site observations on file
- 21 CFR 820.30(c)Design controls6
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
The complete site file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Amherst, Massachusetts
One Form 483 · 2023 · 9 observations
Latest: Form 483, Jul 12, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-12 | 483 Form 483 | Amherst, Massachusetts | 9 | $99 |
Investigators on these documents
FEI number 3017580485 · most recent document Jul 12, 2023
About FEI 3017580485
How many FDA Form 483s has FEI 3017580485 received?
FDA Intel has 1 Form 483 on file for FEI 3017580485; the most recent is dated Jul 12, 2023.
When was FEI 3017580485 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3017580485 is a Form 483 dated Jul 12, 2023, for the site in Amherst, Massachusetts.
What did FDA cite at FEI 3017580485?
The regulations cited most in the observations on file for FEI 3017580485 are 21 CFR 820.30(c) (Design controls), 6 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.