Matheson Tri-Gas, Inc.
Form 483 issued March 11, 2022 · Vernon, California
- Inspection
- Mar 7 – Mar 11, 2022
- Investigator
- John A. Gonzalez
- Observations
- 5
- Pages
- 5
- FEI number
- 3006376135
In short: On March 11, 2022, FDA issued a Form 483 with 5 observations to Matheson Tri-Gas, Inc. in Vernon, California (FEI 3006376135) after an inspection that ran Mar 7 – Mar 11, 2022. The investigator was John A. Gonzalez. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (2×) · 211.180 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Batch production and control records do not include complete information relating to the production and control…
- 03
Batch production and control records do not include the results of any investigations made into any…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
John A. Gonzalez
3 documents · 2021–2022
Cites 211.180 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmMatheson Tri-Gas, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Matheson Tri-Gas, Inc.?
FDA listed 5 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Matheson Tri-Gas, Inc.?
John A. Gonzalez is named on this Form 483, for the inspection of Mar 7 – Mar 11, 2022. Each investigator has a profile showing what they cite most.
When was Matheson Tri-Gas, Inc. inspected by FDA?
The inspection ran Mar 7 – Mar 11, 2022, and the Form 483 is dated March 11, 2022.
How do I get the full Form 483 for Matheson Tri-Gas, 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.