Svelte Medical Systems

FDA inspection history in New Providence, New Jersey, 2021

1
Form 483

Every document, by year

  • Form 483

2021: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2021One Form 483, at New Providence, New Jersey.

Cited most

Across all Svelte Medical Systems observations on file

The complete Svelte Medical Systems file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2021-06-14483 Form 483$99

Investigators on these documents

Frank J. Marciniak (1)

FEI number 3008164981 · most recent document Jun 14, 2021

About Svelte Medical Systems

How many FDA Form 483s has Svelte Medical Systems received?

FDA Intel has 1 Form 483 on file for Svelte Medical Systems; the most recent is dated Jun 14, 2021.

When was Svelte Medical Systems last inspected by FDA?

The most recent FDA inspection document on file for Svelte Medical Systems is a Form 483 dated Jun 14, 2021, for the site in New Providence, New Jersey.

What did FDA cite at Svelte Medical Systems?

The regulations cited most in the observations on file for Svelte Medical Systems are 21 CFR 820.30 (Design controls), 2 times.

Svelte Medical Systems FDA Inspection History & 483s · FDA Intel