Advanced Machine, Inc
Form 483 issued May 2, 2019 · Winchester, Tennessee
- Inspection
- Apr 29 – May 2, 2019
- Investigator
- Mary A. Millner
- Observations
- 2
- Pages
- 5
- FEI number
- 3011061242
In short: On May 2, 2019, FDA issued a Form 483 with 2 observations to Advanced Machine, Inc in Winchester, Tennessee (FEI 3011061242) after an inspection that ran Apr 29 – May 2, 2019. The investigator was Mary A. Millner. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.72 (inspection, measuring, and test equipment).
At a glance
Production & process controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.72(a) (1×) · 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure equipment is routinely calibrated have…
- 02
Procedures for corrective and preventive action have…
This inspection in context
Mary A. Millner
9 documents · 2015–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Tennessee.
The firmAdvanced Machine, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.72(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Machine, Inc?
FDA listed 2 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.72 (inspection, measuring, and test equipment). The opening words of each observation are shown on this page.
Who inspected Advanced Machine, Inc?
Mary A. Millner is named on this Form 483, for the inspection of Apr 29 – May 2, 2019. Each investigator has a profile showing what they cite most.
When was Advanced Machine, Inc inspected by FDA?
The inspection ran Apr 29 – May 2, 2019, and the Form 483 is dated May 2, 2019.
How do I get the full Form 483 for Advanced Machine, 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.