Invivoscribe Technologies, Inc. aka (TVS)
Form 483 issued March 6, 2017 · San Diego, California
- Inspection
- Mar 6, 2017
- Investigators
- Freddy D. Tita-Nwa· Theresa Kirkham
- Observations
- 3
- Pages
- 2
- FEI number
- 3004774989
In short: On March 6, 2017, FDA issued a Form 483 with 3 observations to Invivoscribe Technologies, Inc. aka (TVS) in San Diego, California (FEI 3004774989) after an inspection that ran Mar 6, 2017. The investigators were Freddy D. Tita-Nwa and Theresa Kirkham. Most observations concern management controls and design controls.
At a glance
Management controls and design controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A quality plan has…
- 02
Procedures for design output have…
- 03
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
This inspection in context
Freddy D. Tita-Nwa
1 document · 2017
Cites 820.20 (management responsibility) more than any other section. Most of their documents are for sites in California.
The firmInvivoscribe Technologies, Inc. aka (TVS) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Invivoscribe Technologies, Inc. aka (TVS)?
FDA listed 3 observations on this Form 483, mostly about management controls, design controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Invivoscribe Technologies, Inc. aka (TVS)?
Freddy D. Tita-Nwa and Theresa Kirkham are named on this Form 483, for the inspection of Mar 6, 2017. Each investigator has a profile showing what they cite most.
When was Invivoscribe Technologies, Inc. aka (TVS) inspected by FDA?
The inspection ran Mar 6, 2017, and the Form 483 is dated March 6, 2017.
How do I get the full Form 483 for Invivoscribe Technologies, Inc. aka (TVS)?
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.