Implant Direct Sybron Manufacturing LLC
Form 483 issued May 12, 2021 · Thousand Oaks, California
- Inspection
- May 4 – May 12, 2021
- Investigator
- Kelvin Cheung
- Observations
- 1
- Pages
- 4
- FEI number
- 3001617766
In short: On May 12, 2021, FDA issued a Form 483 with 1 observation to Implant Direct Sybron Manufacturing LLC in Thousand Oaks, California (FEI 3001617766) after an inspection that ran May 4 – May 12, 2021. The investigator was Kelvin Cheung. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
This inspection in context
Kelvin Cheung
5 documents · 2008–2021
Cites 820.100(b) (corrective and preventive action) more than any other section. Most of their documents are for sites in California.
The firmImplant Direct Sybron Manufacturing LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Implant Direct Sybron Manufacturing LLC?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Implant Direct Sybron Manufacturing LLC?
Kelvin Cheung is named on this Form 483, for the inspection of May 4 – May 12, 2021. Each investigator has a profile showing what they cite most.
When was Implant Direct Sybron Manufacturing LLC inspected by FDA?
The inspection ran May 4 – May 12, 2021, and the Form 483 is dated May 12, 2021.
How do I get the full Form 483 for Implant Direct Sybron Manufacturing LLC?
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.