Pajunk Medical Systems, L.P
Amended 483 issued March 18, 2022 · Alpharetta, Georgia
- Inspection
- Mar 10 – Mar 18, 2022
- Investigator
- Melanie W. Pishnery
- Observations
- 2
- Pages
- 7
- FEI number
- 3004076349
In short: On March 18, 2022, FDA issued a Amended 483 with 2 observations to Pajunk Medical Systems, L.P in Alpharetta, Georgia (FEI 3004076349) after an inspection that ran Mar 10 – Mar 18, 2022. The investigator was Melanie W. Pishnery. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.75(b) (1×) · 820.90(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for monitoring and control of process parameters for a validated process have…
- 02
Procedures have not been adequately established to control product that does not…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Melanie W. Pishnery
4 documents · 2022–2025
Cites 211.42(c)(10) (design and construction features) more than any other section. Most of their documents are for sites in Japan.
The firmPajunk Medical Systems, L.P history
The site's inspection history, in date order.
Similar documentsOther sites cited under 820.75(b)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Pajunk Medical Systems, L.P?
FDA listed 2 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Pajunk Medical Systems, L.P?
Melanie W. Pishnery is named on this Amended 483, for the inspection of Mar 10 – Mar 18, 2022. Each investigator has a profile showing what they cite most.
When was Pajunk Medical Systems, L.P inspected by FDA?
The inspection ran Mar 10 – Mar 18, 2022, and the Amended 483 is dated March 18, 2022.
How do I get the full Amended 483 for Pajunk Medical Systems, L.P?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.