AlloSource
Form 483 issued June 11, 2015 · Centennial, Colorado
- Inspection
- May 11 – Jun 11, 2015
- Investigators
- Linda M. Cherry· Marc A. Jackson
- Observations
- 12
- Pages
- 7
- FEI number
- 3000215346
In short: On June 11, 2015, FDA issued a Form 483 with 12 observations to AlloSource in Centennial, Colorado (FEI 3000215346) after an inspection that ran May 11 – Jun 11, 2015. The investigators were Linda M. Cherry and Marc A. Jackson. Most observations concern production & process controls and hCT/P; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and hct/p account for 9 of 12 observations.
Most cited: 21 CFR 820.70 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
- 02
Procedures to control environmental conditions have…
- 03
A validated process was not reviewed and evaluated and revalidated when changes…
- 04
Procedures for the acceptance of in-process product have…
This inspection in context
Linda M. Cherry
2 documents · 2008–2015
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Colorado.
The firmAlloSource history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AlloSource?
FDA listed 12 observations on this Form 483, mostly about production & process controls, hCT/P and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected AlloSource?
Linda M. Cherry and Marc A. Jackson are named on this Form 483, for the inspection of May 11 – Jun 11, 2015. Each investigator has a profile showing what they cite most.
When was AlloSource inspected by FDA?
The inspection ran May 11 – Jun 11, 2015, and the Form 483 is dated June 11, 2015.
How do I get the full Form 483 for AlloSource?
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.