Pontis Orthopaedics, LLC
Form 483 issued July 5, 2018 · San Francisco, California
- Inspection
- Jun 28 – Jul 5, 2018
- Investigator
- Jude C. Dike
- Observations
- 8
- Pages
- 9
- FEI number
- 3010034074
In short: On July 5, 2018, FDA issued a Form 483 with 8 observations to Pontis Orthopaedics, LLC in San Francisco, California (FEI 3010034074) after an inspection that ran Jun 28 – Jul 5, 2018. The investigator was Jude C. Dike. Most observations concern production & process controls and cAPA.
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Corrective and preventive action activities and/or results have…
- 03
Risk analysis is…
- 04
Products that do not conform to specifications…
This inspection in context
Jude C. Dike
9 documents · 2015–2022
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Maryland.
The firmPontis Orthopaedics, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pontis Orthopaedics, LLC?
FDA listed 8 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Pontis Orthopaedics, LLC?
Jude C. Dike is named on this Form 483, for the inspection of Jun 28 – Jul 5, 2018. Each investigator has a profile showing what they cite most.
When was Pontis Orthopaedics, LLC inspected by FDA?
The inspection ran Jun 28 – Jul 5, 2018, and the Form 483 is dated July 5, 2018.
How do I get the full Form 483 for Pontis Orthopaedics, LLC?
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.