Replication Medical, Inc
Form 483 issued August 22, 2018 · Monmouth Junction, New Jersey
- Inspection
- Jul 10 – Aug 22, 2018
- Investigator
- Gobiga Vanniyasingam
- Observations
- 6
- Pages
- 7
- FEI number
- 3004641714
In short: On August 22, 2018, FDA issued a Form 483 with 6 observations to Replication Medical, Inc in Monmouth Junction, New Jersey (FEI 3004641714) after an inspection that ran Jul 10 – Aug 22, 2018. The investigator was Gobiga Vanniyasingam. Most observations concern records & documents and cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
Records & documents and capa account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
A device master record…
- 02
Corrective and preventive action activitie s aind/or results have not been…
- 03
The device history record does not demonstrate that the device was manufactured in accordance with…
- 04
Production processes were not controlled to ensure that a device…
This inspection in context
Gobiga Vanniyasingam
4 documents · 2018–2019
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in New Jersey.
The firmReplication Medical, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.181
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Replication Medical, Inc?
FDA listed 6 observations on this Form 483, mostly about records & documents, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Replication Medical, Inc?
Gobiga Vanniyasingam is named on this Form 483, for the inspection of Jul 10 – Aug 22, 2018. Each investigator has a profile showing what they cite most.
When was Replication Medical, Inc inspected by FDA?
The inspection ran Jul 10 – Aug 22, 2018, and the Form 483 is dated August 22, 2018.
How do I get the full Form 483 for Replication Medical, Inc?
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.