Carlsbad Technology, Inc.
Form 483 issued November 5, 2021 · Carlsbad, California
- Inspection
- Oct 28 – Nov 5, 2021
- Investigator
- Saied A. Asbagh
- Observations
- 1
- Pages
- 3
- FEI number
- 1000135190
In short: On November 5, 2021, FDA issued a Form 483 with 1 observation to Carlsbad Technology, Inc. in Carlsbad, California (FEI 1000135190) after an inspection that ran Oct 28 – Nov 5, 2021. The investigator was Saied A. Asbagh. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Saied A. Asbagh
12 documents · 2016–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmCarlsbad Technology, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Carlsbad Technology, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Carlsbad Technology, Inc.?
Saied A. Asbagh is named on this Form 483, for the inspection of Oct 28 – Nov 5, 2021. Each investigator has a profile showing what they cite most.
When was Carlsbad Technology, Inc. inspected by FDA?
The inspection ran Oct 28 – Nov 5, 2021, and the Form 483 is dated November 5, 2021.
How do I get the full Form 483 for Carlsbad 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.