Medical-technical Gases, Inc.
Form 483 issued October 12, 2023 · North Billerica, Massachusetts
- Inspection
- Oct 2 – Oct 12, 2023
- Investigator
- Jonathan G. Matrisciano
- Observations
- 2
- Pages
- 3
- FEI number
- 1215362
In short: On October 12, 2023, FDA issued a Form 483 with 2 observations to Medical-technical Gases, Inc. in North Billerica, Massachusetts (FEI 1215362) after an inspection that ran Oct 2 – Oct 12, 2023. The investigator was Jonathan G. Matrisciano. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.188(b)(8) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
The batch production and control records are deficient in that they do not include specimen…
This inspection in context
Jonathan G. Matrisciano
29 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmMedical-technical Gases, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medical-technical Gases, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Medical-technical Gases, Inc.?
Jonathan G. Matrisciano is named on this Form 483, for the inspection of Oct 2 – Oct 12, 2023. Each investigator has a profile showing what they cite most.
When was Medical-technical Gases, Inc. inspected by FDA?
The inspection ran Oct 2 – Oct 12, 2023, and the Form 483 is dated October 12, 2023.
How do I get the full Form 483 for Medical-technical Gases, 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.