Liberty Engineering Inc
Form 483 issued December 18, 2019 · Newton, Massachusetts
- Inspection
- Dec 12 – Dec 18, 2019
- Investigator
- Sara M. Onyango
- Observations
- 6
- Pages
- 6
- FEI number
- 3004114361
In short: On December 18, 2019, FDA issued a Form 483 with 6 observations to Liberty Engineering Inc in Newton, Massachusetts (FEI 3004114361) after an inspection that ran Dec 12 – Dec 18, 2019. The investigator was Sara M. Onyango. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure equipment is routinely calibrated have…
- 02
The evaluation of potential…
- 03
In-process inspections, tests, or other verification activities and…
- 04
Procedures for rework of nonconforming product have…
This inspection in context
Sara M. Onyango
9 documents · 2019–2026
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmLiberty Engineering 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 Liberty Engineering Inc?
FDA listed 6 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Liberty Engineering Inc?
Sara M. Onyango is named on this Form 483, for the inspection of Dec 12 – Dec 18, 2019. Each investigator has a profile showing what they cite most.
When was Liberty Engineering Inc inspected by FDA?
The inspection ran Dec 12 – Dec 18, 2019, and the Form 483 is dated December 18, 2019.
How do I get the full Form 483 for Liberty Engineering 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.