MAVIDON MEDICAL PRODUCTS
Form 483 issued August 5, 2025 · Flat Rock, North Carolina
- Inspection
- Jul 21 – Aug 5, 2025
- Investigator
- Benjamin E. Bowen
- Observations
- 13
- Pages
- 19
- FEI number
- 3017189082
In short: On August 5, 2025, FDA issued a Form 483 with 13 observations to MAVIDON MEDICAL PRODUCTS in Flat Rock, North Carolina (FEI 3017189082) after an inspection that ran Jul 21 – Aug 5, 2025. The investigator was Benjamin E. Bowen. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and capa account for 11 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Products that do not conform to specifications…
- 03
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Benjamin E. Bowen
4 documents · 2021–2025
Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in Tennessee.
The firmMAVIDON MEDICAL PRODUCTS history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MAVIDON MEDICAL PRODUCTS?
FDA listed 13 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected MAVIDON MEDICAL PRODUCTS?
Benjamin E. Bowen is named on this Form 483, for the inspection of Jul 21 – Aug 5, 2025. Each investigator has a profile showing what they cite most.
When was MAVIDON MEDICAL PRODUCTS inspected by FDA?
The inspection ran Jul 21 – Aug 5, 2025, and the Form 483 is dated August 5, 2025.
How do I get the full Form 483 for MAVIDON MEDICAL PRODUCTS?
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.