Micron Solutions Inc
Form 483 issued February 16, 2022 · Fitchburg, Massachusetts
- Inspection
- Feb 14 – Feb 16, 2022
- Investigator
- John A. Sciacchitano
- Observations
- 3
- Pages
- 4
- FEI number
- 1000138247
In short: On February 16, 2022, FDA issued a Form 483 with 3 observations to Micron Solutions Inc in Fitchburg, Massachusetts (FEI 1000138247) after an inspection that ran Feb 14 – Feb 16, 2022. The investigator was John A. Sciacchitano. Most observations concern cAPA and production & process controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures for corrective and preventive action have…
- 03
The type and extent of control to be exercised over suppliers…
This inspection in context
John A. Sciacchitano
2 documents · 2022–2023
Cites 803.52 (if i am a manufacturer, what information must i submit in my individual adverse event reports?) more than any other section. Most of their documents are for sites in Massachusetts.
The firmMicron Solutions Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Micron Solutions Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Micron Solutions Inc?
John A. Sciacchitano is named on this Form 483, for the inspection of Feb 14 – Feb 16, 2022. Each investigator has a profile showing what they cite most.
When was Micron Solutions Inc inspected by FDA?
The inspection ran Feb 14 – Feb 16, 2022, and the Form 483 is dated February 16, 2022.
How do I get the full Form 483 for Micron Solutions 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.