FDA
Last FDA Inspection: Feb. 2008
FDA Drug Establishment Registration # 1063707
http://www.fda.gov/cder/dfars/docs/querydrls.htm
Labeler Code # 55049
Medical Device: Historically, Span has registered with the FDA as a Medical Device Establishment and provided Medical Device Listing Forms for each Medical Device product that we manufacture or package. Recently, the FDA published the following document on their website – please click on the link/see below.
http://www.fda.gov/cdrh/registration/whomust.html
Per the definitions provided in the FDA documents and per Span’s discussions with the FDA - we determined that:
Span is the Contract manufacturer and performs NO COMMERCIAL DISTRIBUTION of any Medical Device Products.
You – the customer – are the Specification Developer.
Span is not required to be registered with the FDA as a Medical Device Establishment. Span is not required to provide Medical Device Listings for the Medical Device products that Span manufactures &/or packages.
DEA
http://www.usdoj.gov/dea/index.htm
DEA Registration – Span has been registered with the DEA previously - during production of products requiring DEA Registration. Span has not manufactured or packaged any product requiring DEA registration in the last 2 years and therefore by DEA Regulations - cannot renew again until handling a product requiring DEA registration. Span was registered as a Chemical Manufacturer, Importer & Exporter.
EPA
Establishment # 71979 - SC – 001
http://www.epa.gov/compliance/monitoring/programs/fifra/establishments.html
South Carolina Board of Pharmacy
http://www.llr.state.sc.us/POL/Pharmacy/
South Carolina Drug Outlet Permit # 55007523
South Carolina Department of LLR (Labor, Licensing and Regulation)
ASQ
http://www.asq.org/
ASQ (American Society for Quality) - (Sustaining Member # 1344079)
AAMI
http://www.aami.org/
AAMI (Association for the Advancement of Medical Instrumentation) Member since March 8, 2006.
