Consolidated Machine Corp
Form 483 issued November 27, 2019 · Billerica, Massachusetts
- Inspection
- Nov 26 – Nov 27, 2019
- Investigator
- James P. Finn
- Observations
- 2
- Pages
- 3
- FEI number
- 1219189
In short: On November 27, 2019, FDA issued a Form 483 with 2 observations to Consolidated Machine Corp in Billerica, Massachusetts (FEI 1219189) after an inspection that ran Nov 26 – Nov 27, 2019. The investigator was James P. Finn. Most observations concern design controls and management controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.30(e) (1×) · 820.22 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design review have…
- 02
Quality audits were not performed at sufficient frequency to determine whether the quality system activities and…
This inspection in context
James P. Finn
10 documents · 2019–2026
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Massachusetts.
The firmConsolidated Machine Corp history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Consolidated Machine Corp?
FDA listed 2 observations on this Form 483, mostly about design controls and management controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Consolidated Machine Corp?
James P. Finn is named on this Form 483, for the inspection of Nov 26 – Nov 27, 2019. Each investigator has a profile showing what they cite most.
When was Consolidated Machine Corp inspected by FDA?
The inspection ran Nov 26 – Nov 27, 2019, and the Form 483 is dated November 27, 2019.
How do I get the full Form 483 for Consolidated Machine Corp?
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.