Pentax of America Inc
Form 483 issued September 27, 2018 · Montvale, New Jersey
- Inspection
- Aug 15 – Sep 27, 2018
- Investigator
- David H. Smith
- Observations
- 5
- Pages
- 6
- FEI number
- 1000080301
In short: On September 27, 2018, FDA issued a Form 483 with 5 observations to Pentax of America Inc in Montvale, New Jersey (FEI 1000080301) after an inspection that ran Aug 15 – Sep 27, 2018. The investigator was David H. Smith. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
4 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
Service reports that represent MDR reportable events were not automatically considered complaints and processed in accordance…
- 04
Procedures for corrective and preventive action have…
This inspection in context
David H. Smith
1 document · 2018
Cites 803.50(a)(1) (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in New Jersey.
The firmPentax of America Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pentax of America Inc?
FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Pentax of America Inc?
David H. Smith is named on this Form 483, for the inspection of Aug 15 – Sep 27, 2018. Each investigator has a profile showing what they cite most.
When was Pentax of America Inc inspected by FDA?
The inspection ran Aug 15 – Sep 27, 2018, and the Form 483 is dated September 27, 2018.
How do I get the full Form 483 for Pentax of America 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.