Technichem Corp.
Form 483 issued March 9, 2018 · Anaheim, California
- Inspection
- Feb 7 – Mar 9, 2018
- Investigator
- Darren S. Brown
- Observations
- 7
- Pages
- 9
- FEI number
- 3012112742
In short: On March 9, 2018, FDA issued a Form 483 with 7 observations to Technichem Corp. in Anaheim, California (FEI 3012112742) after an inspection that ran Feb 7 – Mar 9, 2018. The investigator was Darren S. Brown. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
There is no written testing program designed to assess the stability…
- 04
Each lot of components, drug product containers and closures is not withheld from use until the…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmTechnichem Corp. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Technichem Corp.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected Technichem Corp.?
Darren S. Brown is named on this Form 483, for the inspection of Feb 7 – Mar 9, 2018. Each investigator has a profile showing what they cite most.
When was Technichem Corp. inspected by FDA?
The inspection ran Feb 7 – Mar 9, 2018, and the Form 483 is dated March 9, 2018.
How do I get the full Form 483 for Technichem Corp.?
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.