US Stem Cell Clinic, LLC
FDA inspection history in Sunrise, Florida, 2017
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2017: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One warning letter and one Form 483, at Sunrise, Florida.
Cited most
Across all US Stem Cell Clinic observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.165(b)Testing and release for distribution1
The complete US Stem Cell Clinic file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Sunrise, Florida
One warning letter and one Form 483 · 2017 · 12 observations
Latest: Warning letter, Aug 24, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-08-24 | Warning letter Warning letter | Sunrise, Florida | — | $99 |
| 2017-05-11 | 483 Form 483 | Sunrise, Florida | 12 | $99 |
Investigators on these documents
FEI number 3011837323 · most recent document Aug 24, 2017
About US Stem Cell Clinic, LLC
How many FDA Form 483s has US Stem Cell Clinic, LLC received?
FDA Intel has 1 Form 483 on file for US Stem Cell Clinic, LLC; the most recent is dated May 11, 2017.
When was US Stem Cell Clinic, LLC last inspected by FDA?
The most recent FDA inspection document on file for US Stem Cell Clinic, LLC is a Form 483 dated May 11, 2017, for the site in Sunrise, Florida.
What did FDA cite at US Stem Cell Clinic, LLC?
The regulations cited most in the observations on file for US Stem Cell Clinic, LLC are 21 CFR 211.42(c)(10)(iv) (Design and construction features), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.
Has US Stem Cell Clinic, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for US Stem Cell Clinic, LLC; the most recent is dated Aug 24, 2017.