Transfer Technology, Inc.
Form 483 issued October 11, 2019 · Huntington Beach, California
- Inspection
- Oct 11, 2019
- Investigator
- Kevin N. Tran
- Observations
- 12
- Pages
- 8
- FEI number
- 3009494532
In short: On October 11, 2019, FDA issued a Form 483 with 12 observations to Transfer Technology, Inc. in Huntington Beach, California (FEI 3009494532) after an inspection that ran Oct 11, 2019. The investigator was Kevin N. Tran. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 8 of 12 observations.
Most cited: 21 CFR 820.30(h) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The design was not validated using initial production units, lots or…
- 02
Procedures for design change have…
- 03
Sampling plans are not based…
- 04
Design input requirements were…
This inspection in context
Kevin N. Tran
7 documents · 2019–2025
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmTransfer Technology, 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 820.30(h)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Transfer Technology, Inc.?
FDA listed 12 observations on this Form 483, mostly about design controls, production & process controls and records & documents. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Transfer Technology, Inc.?
Kevin N. Tran is named on this Form 483, for the inspection of Oct 11, 2019. Each investigator has a profile showing what they cite most.
When was Transfer Technology, Inc. inspected by FDA?
The inspection ran Oct 11, 2019, and the Form 483 is dated October 11, 2019.
How do I get the full Form 483 for Transfer Technology, 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.