Pajunk Medical Systems, L.P

FDA inspection history in Alpharetta, Georgia, 2022

1
Form 483

Every document, by year

  • Form 483

2022: one amended 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2022One amended 483, at Alpharetta, Georgia.

Cited most

Across all Pajunk Medical Systems observations on file

The complete Pajunk 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
2022-03-18Amended 483 Amended 483$99

Investigators on these documents

Melanie W. Pishnery (1)

FEI number 3004076349 · most recent document Mar 18, 2022

About Pajunk Medical Systems, L.P

How many FDA Form 483s has Pajunk Medical Systems, L.P received?

FDA Intel has 1 Form 483 on file for Pajunk Medical Systems, L.P; the most recent is dated Mar 18, 2022.

When was Pajunk Medical Systems, L.P last inspected by FDA?

The most recent FDA inspection document on file for Pajunk Medical Systems, L.P is a Form 483 dated Mar 18, 2022, for the site in Alpharetta, Georgia.

What did FDA cite at Pajunk Medical Systems, L.P?

The regulations cited most in the observations on file for Pajunk Medical Systems, L.P are 21 CFR 820.75(b) (Process validation), 1 time; 21 CFR 820.90(a) (Nonconforming product), 1 time.