Custom Research Labs Inc
Form 483 issued June 1, 2016 · Gardena, California
- Inspection
- May 23 – Jun 1, 2016
- Investigator
- Darren S. Brown
- Observations
- 10
- Pages
- 6
- FEI number
- 3008268262
In short: On June 1, 2016, FDA issued a Form 483 with 10 observations to Custom Research Labs Inc in Gardena, California (FEI 3008268262) after an inspection that ran May 23 – Jun 1, 2016. The investigator was Darren S. Brown. Most observations concern laboratory controls and facilities & equipment.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Routine calibration of electronic equipment is not performed according to a written program designed…
- 04
The written stability program for drug products does not include reliable, meaningful…
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 firmCustom Research Labs 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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Research Labs Inc?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, facilities & equipment and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Custom Research Labs Inc?
Darren S. Brown is named on this Form 483, for the inspection of May 23 – Jun 1, 2016. Each investigator has a profile showing what they cite most.
When was Custom Research Labs Inc inspected by FDA?
The inspection ran May 23 – Jun 1, 2016, and the Form 483 is dated June 1, 2016.
How do I get the full Form 483 for Custom Research Labs 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.