|
|
The Cherokee plant is a bulk chemical manufacturing site for
the active pharmaceutical ingredient in a number of human and animal
health products. The facility is located in the borough of Riverside,
Pa., across the river from Danville. The site encompasses 323 acres,
with 127 acres inside the fence-line. There is a large available
fermentation facility which until 2005, produced xanthan gum and
since has manufactured various fermented products for external bio-technical
companies.
FDA Audit History
The Cherokee site has a long track record of collaborating
with the FDA to insure we continue to manufacture and supply, quality products
to our customers.
| |
Audits
|
Observations
|
|
2000
|
1 (CDER)
|
0
|
|
2001
|
1 (CDER)
|
1
|
|
2002
|
1 (CDER)
|
0
|
|
1 (CBER)
|
3
|
|
2003
|
0
|
0
|
|
2004
|
0
|
0
|
|
2005
|
1 (CDER)
|
1
|
|
1 (CBER)
|
4
|
|
2006
|
1 (CDER)
|
0
|
|
2007
|
0
|
0
|
|
|