Medicraft, Inc
Form 483 issued November 27, 2024 · Elmwood Park, New Jersey
- Inspection
- Nov 20 – Nov 27, 2024
- Investigator
- Colin E. Tack
- Observations
- 7
- Pages
- 8
- FEI number
- 3009538923
In short: On November 27, 2024, FDA issued a Form 483 with 7 observations to Medicraft, Inc in Elmwood Park, New Jersey (FEI 3009538923) after an inspection that ran Nov 20 – Nov 27, 2024. The investigator was Colin E. Tack. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
6 of 7 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for monitoring and control of process parameters for a validated process have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Schedules for the adjustment, cleaning, and other maintenance of equipment…
- 04
Procedures for acceptance of incoming product have…
This inspection in context
Colin E. Tack
8 documents · 2019–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmMedicraft, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medicraft, Inc?
FDA listed 7 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Medicraft, Inc?
Colin E. Tack is named on this Form 483, for the inspection of Nov 20 – Nov 27, 2024. Each investigator has a profile showing what they cite most.
When was Medicraft, Inc inspected by FDA?
The inspection ran Nov 20 – Nov 27, 2024, and the Form 483 is dated November 27, 2024.
How do I get the full Form 483 for Medicraft, 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.