American CryoStem Corporation
FDA inspection history across 2 sites, 2017 to 2018
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2017: one Form 483; 2018: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18One Form 483 and one close-out letter, at Monmouth Junction, New Jersey and Eatontown, New Jersey.
Cited most
Across all American CryoStem observations on file
- 21 CFR 211.42(b)Design and construction features3
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.46(c)Ventilation, air filtration, air heating and cooling1
The complete American CryoStem 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
Eatontown, New Jersey
One close-out letter · 2018
Latest: Close-out, Jan 3, 2018 →Monmouth Junction, New Jersey
One Form 483 · 2017 · 9 observations
Latest: Form 483, Jul 26, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-01-03 | Close-out Close-out letter | Eatontown, New Jersey | — | $99 |
| 2017-07-26 | 483 Form 483 | Monmouth Junction, New Jersey | 9 | $99 |
Investigators on these documents
FEI number 3008307548 · most recent document Jan 3, 2018
About American CryoStem Corporation
How many FDA Form 483s has American CryoStem Corporation received?
FDA Intel has 1 Form 483 on file for American CryoStem Corporation; the most recent is dated Jul 26, 2017.
When was American CryoStem Corporation last inspected by FDA?
The most recent FDA inspection document on file for American CryoStem Corporation is a Form 483 dated Jul 26, 2017, for the site in Monmouth Junction, New Jersey.
What did FDA cite at American CryoStem Corporation?
The regulations cited most in the observations on file for American CryoStem Corporation are 21 CFR 211.42(b) (Design and construction features), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.