California Stem Cell Treatment Center/Cell Surgical Network
Form 483 issued July 27, 2017 · Beverly Hills, California
- Inspection
- Jul 21 – Jul 27, 2017
- Investigators
- Darla J. Christopher· Michele L. Forster
- Observations
- 13
- Pages
- 11
- FEI number
- 3013670025
In short: On July 27, 2017, FDA issued a Form 483 with 13 observations to California Stem Cell Treatment Center/Cell Surgical Network in Beverly Hills, California (FEI 3013670025) after an inspection that ran Jul 21 – Jul 27, 2017. The investigators were Darla J. Christopher and Michele L. Forster. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Darla J. Christopher
10 documents · 2010–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmCalifornia Stem Cell Treatment Center/Cell Surgical Network history
The site's inspection history, in date order.
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 California Stem Cell Treatment Center/Cell Surgical Network?
FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected California Stem Cell Treatment Center/Cell Surgical Network?
Darla J. Christopher and Michele L. Forster are named on this Form 483, for the inspection of Jul 21 – Jul 27, 2017. Each investigator has a profile showing what they cite most.
When was California Stem Cell Treatment Center/Cell Surgical Network inspected by FDA?
The inspection ran Jul 21 – Jul 27, 2017, and the Form 483 is dated July 27, 2017.
How do I get the full Form 483 for California Stem Cell Treatment Center/Cell Surgical Network?
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.