Moldex-Metric, Inc
Form 483 issued March 5, 2026 · Culver City, California
- Inspection
- Mar 3 – Mar 5, 2026
- Investigator
- Sarah A. Hassas
- Observations
- 2
- Pages
- 3
- FEI number
- 1000098753
In short: On March 5, 2026, FDA issued a Form 483 with 2 observations to Moldex-Metric, Inc in Culver City, California (FEI 1000098753) after an inspection that ran Mar 3 – Mar 5, 2026. The investigator was Sarah A. Hassas. The most-cited regulation is 21 CFR 7.1 (scope).
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.1
Records of risk management activities in product…
- 02ISO 13485:2016 Clause 7.3.10
A design and development file was not maintained for each medical device type…
This inspection in context
Sarah A. Hassas
5 documents · 2015–2026
Cites ISO 13485:2016 Clause 7.3.10 (definitions) more than any other section. Most of their documents are for sites in California.
The firmMoldex-Metric, Inc history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Moldex-Metric, Inc?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 7.1 (scope). The opening words of each observation are shown on this page.
Who inspected Moldex-Metric, Inc?
Sarah A. Hassas is named on this Form 483, for the inspection of Mar 3 – Mar 5, 2026. Each investigator has a profile showing what they cite most.
When was Moldex-Metric, Inc inspected by FDA?
The inspection ran Mar 3 – Mar 5, 2026, and the Form 483 is dated March 5, 2026.
How do I get the full Form 483 for Moldex-Metric, 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.