US Stem Cell Clinic, LLC
Form 483 issued May 11, 2017 · Sunrise, Florida
- Inspection
- May 11, 2017
- Investigators
- Colleen M. Aspinwall· Shavon L. Square
- Observations
- 12
- Pages
- 7
- FEI number
- 3011837323
In short: On May 11, 2017, FDA issued a Form 483 with 12 observations to US Stem Cell Clinic, LLC in Sunrise, Florida (FEI 3011837323) after an inspection that ran May 11, 2017. The investigators were Colleen M. Aspinwall and Shavon L. Square. 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
Procedures designed to prevent microbiological 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 ai·eas ai·e deficient regai·ding the system…
- 04
Aseptic processing ai·eas ai·e deficient regai·ding the system for cleaning an d disinfecting the room and…
This inspection in context
Colleen M. Aspinwall
1 document · 2017
Cites 211.42(c)(10)(iv) (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmUS Stem Cell Clinic, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at US Stem Cell Clinic, LLC?
FDA listed 12 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 US Stem Cell Clinic, LLC?
Colleen M. Aspinwall and Shavon L. Square are named on this Form 483, for the inspection of May 11, 2017. Each investigator has a profile showing what they cite most.
When was US Stem Cell Clinic, LLC inspected by FDA?
The inspection ran May 11, 2017, and the Form 483 is dated May 11, 2017.
How do I get the full Form 483 for US Stem Cell Clinic, LLC?
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.