AlloSource
FDA inspection history in Centennial, Colorado, 2002 to 2015
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2002: one warning letter; 2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2002One warning letter, at Centennial, Colorado.
- 2015One Form 483, at Centennial, Colorado.
Cited most
Across all AlloSource observations on file
- 21 CFR 820.70Production and process controls2
- 21 CFR 1271.210Supplies and reagents1
- 21 CFR 1271.225Process changes1
- 21 CFR 1271.60What quarantine and other requirements apply before the donor-eligibility determination is complete?1
- 21 CFR 820.120Device labeling1
The complete AlloSource 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
Centennial, Colorado
One Form 483 and one warning letter · 2002 to 2015 · 12 observations
Latest: Form 483, Jun 11, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-06-11 | 483 Form 483 | Centennial, Colorado | 12 | $99 |
| 2002-04-03 | Warning letter Warning letter | Centennial, Colorado | — | $99 |
Investigators on these documents
FEI number 3000215346 · most recent document Jun 11, 2015
About AlloSource
How many FDA Form 483s has AlloSource received?
FDA Intel has 1 Form 483 on file for AlloSource; the most recent is dated Jun 11, 2015.
When was AlloSource last inspected by FDA?
The most recent FDA inspection document on file for AlloSource is a Form 483 dated Jun 11, 2015, for the site in Centennial, Colorado.
What did FDA cite at AlloSource?
The regulations cited most in the observations on file for AlloSource are 21 CFR 820.70 (Production and process controls), 2 times; 21 CFR 1271.210 (Supplies and reagents), 1 time; 21 CFR 1271.225 (Process changes), 1 time.
Has AlloSource received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for AlloSource; the most recent is dated Apr 3, 2002.