PFM Medical Titanium GmbH
Form 483 issued February 11, 2016 · Nurnberg, Germany
- Inspection
- Feb 8 – Feb 11, 2016
- Investigator
- Maryam Tabatabaie
- Observations
- 8
- Pages
- 4
- FEI number
- 3003936139
In short: On February 11, 2016, FDA issued a Form 483 with 8 observations to PFM Medical Titanium GmbH in Nurnberg, Germany (FEI 3003936139) after an inspection that ran Feb 8 – Feb 11, 2016. The investigator was Maryam Tabatabaie. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
CAPA and production & process controls account for 7 of 8 observations.
Most cited: 21 CFR 820.198 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design validation have…
- 02
Procedures for acceptance activities have…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
Written MDR procedures have…
This inspection in context
Maryam Tabatabaie
11 documents · 2016–2024
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Rhode Island.
The firmPFM Medical Titanium GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PFM Medical Titanium GmbH?
FDA listed 8 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected PFM Medical Titanium GmbH?
Maryam Tabatabaie is named on this Form 483, for the inspection of Feb 8 – Feb 11, 2016. Each investigator has a profile showing what they cite most.
When was PFM Medical Titanium GmbH inspected by FDA?
The inspection ran Feb 8 – Feb 11, 2016, and the Form 483 is dated February 11, 2016.
How do I get the full Form 483 for PFM Medical Titanium GmbH?
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.