Pac-dent, Inc
Form 483 issued March 12, 2026 · Brea, California
- Inspection
- Mar 10 – Mar 12, 2026
- Investigator
- Mario-Ian M. Alintanahin
- Observations
- 2
- Pages
- 4
- FEI number
- 3000719964
In short: On March 12, 2026, FDA issued a Form 483 with 2 observations to Pac-dent, Inc in Brea, California (FEI 3000719964) after an inspection that ran Mar 10 – Mar 12, 2026. The investigator was Mario-Ian M. Alintanahin. The most-cited regulation is 21 CFR 830.310 (information required for unique device identification).
What FDA observed
Preview: the opening words of each observation- 0121 CFR 830.310(b)
The correct unique device identifier (UDI) information regarding device identifier portion of the UDI assigned to…
- 02ISO 13485:2016 Clause 7.4.1
Records of the results of re-evaluation of supplier capability or…
This inspection in context
Mario-Ian M. Alintanahin
1 document · 2026
Cites ISO 13485:2016 Clause 7.4.1 more than any other section. Most of their documents are for sites in California.
The firmPac-dent, Inc history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Pac-dent, Inc?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 830.310 (information required for unique device identification). The opening words of each observation are shown on this page.
Who inspected Pac-dent, Inc?
Mario-Ian M. Alintanahin is named on this Form 483, for the inspection of Mar 10 – Mar 12, 2026. Each investigator has a profile showing what they cite most.
When was Pac-dent, Inc inspected by FDA?
The inspection ran Mar 10 – Mar 12, 2026, and the Form 483 is dated March 12, 2026.
How do I get the full Form 483 for Pac-dent, 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.