Tecomet, Inc
Form 483 issued May 10, 2019 · Pennsauken, New Jersey
- Inspection
- Apr 29 – May 10, 2019
- Investigator
- Tiki Dixon
- Observations
- 5
- Pages
- 5
- FEI number
- 3011660613
In short: On May 10, 2019, FDA issued a Form 483 with 5 observations to Tecomet, Inc in Pennsauken, New Jersey (FEI 3011660613) after an inspection that ran Apr 29 – May 10, 2019. The investigator was Tiki Dixon. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
At a glance
4 of 5 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for finished device acceptance have…
- 02
Procedures for the acceptance and control of in-process product have…
- 03
Procedures for corrective and preventive action have…
- 04
Procedures for acceptance of incoming product have…
This inspection in context
Tiki Dixon
10 documents · 2016–2024
Cites 820.80(a) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in Virginia.
The firmTecomet, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tecomet, Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance). The opening words of each observation are shown on this page.
Who inspected Tecomet, Inc?
Tiki Dixon is named on this Form 483, for the inspection of Apr 29 – May 10, 2019. Each investigator has a profile showing what they cite most.
When was Tecomet, Inc inspected by FDA?
The inspection ran Apr 29 – May 10, 2019, and the Form 483 is dated May 10, 2019.
How do I get the full Form 483 for Tecomet, 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.