Biosearch Medical Products, Inc
Form 483 issued October 11, 2022 · Concord, North Carolina
- Inspection
- Sep 28 – Oct 11, 2022
- Investigator
- Gamal A. Norton
- Observations
- 6
- Pages
- 5
- FEI number
- 2242547
In short: On October 11, 2022, FDA issued a Form 483 with 6 observations to Biosearch Medical Products, Inc in Concord, North Carolina (FEI 2242547) after an inspection that ran Sep 28 – Oct 11, 2022. The investigator was Gamal A. Norton. Most observations concern production & process controls and records & documents.
At a glance
Production & process controls and records & documents account for 5 of 6 observations.
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
Potential suppliers were not evaluated and selected based on their ability…
- 03
Procedures for acceptance of incoming product…
- 04
A device master record…
This inspection in context
Gamal A. Norton
16 documents · 2003–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmBiosearch Medical Products, Inc 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 Biosearch Medical Products, Inc?
FDA listed 6 observations on this Form 483, mostly about production & process controls, records & documents and management controls. The opening words of each observation are shown on this page.
Who inspected Biosearch Medical Products, Inc?
Gamal A. Norton is named on this Form 483, for the inspection of Sep 28 – Oct 11, 2022. Each investigator has a profile showing what they cite most.
When was Biosearch Medical Products, Inc inspected by FDA?
The inspection ran Sep 28 – Oct 11, 2022, and the Form 483 is dated October 11, 2022.
How do I get the full Form 483 for Biosearch Medical Products, 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.