Plasdent Corporation
Form 483 issued November 22, 2019 · Pomona, California
- Inspection
- Nov 18 – Nov 22, 2019
- Investigator
- Marlo I. Alintanahin
- Observations
- 5
- Pages
- 5
- FEI number
- 1000220911
In short: On November 22, 2019, FDA issued a Form 483 with 5 observations to Plasdent Corporation in Pomona, California (FEI 1000220911) after an inspection that ran Nov 18 – Nov 22, 2019. The investigator was Marlo I. Alintanahin. Most observations concern cAPA and production & process controls.
At a glance
3 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to control labeling activities have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Written MDR procedures have not been…
- 04
Procedures for corrective and preventive action…
This inspection in context
Marlo I. Alintanahin
2 documents · 2019
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in California.
The firmPlasdent Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.120
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Plasdent Corporation?
FDA listed 5 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The opening words of each observation are shown on this page.
Who inspected Plasdent Corporation?
Marlo I. Alintanahin is named on this Form 483, for the inspection of Nov 18 – Nov 22, 2019. Each investigator has a profile showing what they cite most.
When was Plasdent Corporation inspected by FDA?
The inspection ran Nov 18 – Nov 22, 2019, and the Form 483 is dated November 22, 2019.
How do I get the full Form 483 for Plasdent Corporation?
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.