California Stem Cell Treatment
Form 483 issued July 26, 2017 · Rancho Mirage, California
- Inspection
- Jul 17 – Jul 26, 2017
- Investigators
- Cynthia Jim· William F. Lagud
- Observations
- 11
- Pages
- 12
- FEI number
- 3009436720
In short: On July 26, 2017, FDA issued a Form 483 with 11 observations to California Stem Cell Treatment in Rancho Mirage, California (FEI 3009436720) after an inspection that ran Jul 17 – Jul 26, 2017. The investigators were Cynthia Jim and William F. Lagud. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microb iological contamination of drug products purporting to be sterile are not…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
The identity of each component of a drug product is not verified by conducting at least…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmCalifornia Stem Cell Treatment history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at California Stem Cell Treatment?
FDA listed 11 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected California Stem Cell Treatment?
Cynthia Jim and William F. Lagud are named on this Form 483, for the inspection of Jul 17 – Jul 26, 2017. Each investigator has a profile showing what they cite most.
When was California Stem Cell Treatment inspected by FDA?
The inspection ran Jul 17 – Jul 26, 2017, and the Form 483 is dated July 26, 2017.
How do I get the full Form 483 for California Stem Cell Treatment?
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.