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Home > Services > Quality Management > Regulatory History

PMRS has established and maintained a good working relationship with several regulatory authorities. Our current licensing and registration information is as follows:

202 Precision Road:

FDA Facility Establishment No.: 3004752030
PA Wholesale Prescription Drug Distributor Lic. No.: 8000001596
PA Drug Mfg. Registration No.: 1000003011
DEA Controlled Substances Registrations:

  Manufacturing: RP0218099 (II, IV)
Analytical: RP0334639 (I-V)

427 Sargon Way:

FDA Facility Establishment No.: 2530921
PA Wholesale Prescription Drug Distributor License No.: 8000000437
PA Drug Mfg Registration No.: 1000002331


Regulatory Inspections

FDA:

  February 1996; February 1998; August 1998; January 1999; July 1999; September 1999; July 2000; March 2001; April 2003; February 2005; June 2005; February 2006; October 2006; March 2007; August 2007
DEA:
  September 1997; October 2000; December 2003; January 2006
MHRA (UK):
  November 2000; June 2003; July 2006
MPA (Sweden):
  August 2006

These regulatory inspections include satisfactory product inspections by both European and American agencies.

In addition, PMRS holds ISO9001:2000 and ISO14001 registrations for "Contract Manufacturing and Analytical Services for the Pharmaceutical Industry".

PMRS is a proud recipient of the Green Dove Award, signifying our commitment to the environment
   
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