Reference Source

Samson Medical Technologies, LLC · 66-57 · UNITED STATES

For Samson Medical Technologies, LLC · 66-57 · UNITED STATES, import alert is 66-57; import alert name is "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."; country is UNITED STATES; product is All prescription drugs (finished dosage form); product code is 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs; date published is 09/10/2009; address is 1815 Garden Ave , Cherry Hill, NJ 08003-2303 UNITED STATES, verified against its source on 2026-09-16.

Firm
Samson Medical Technologies, LLC verified
Import alert
66-57
Import alert name
"Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."
Country
UNITED STATES verified
Address
1815 Garden Ave , Cherry Hill, NJ 08003-2303 UNITED STATES verified
Date published
09/10/2009 verified
Product code
55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs each item verified
Product
All prescription drugs (finished dosage form) verified
FDA notes
10/16/2006 ;Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 | All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Samson Medical Technologies, LLC Date Published : 09/10/2009 1815 Garden Ave , Cherry Hill, NJ 08003-2303 UNITED STATES 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/02/2021 Desc: All prescription drugs (finished dosage form) Notes: 10/16/2006 ;Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 56 - - - -- Antibiotics (Human/Animal) Date Published: 09/10/2009 Notes: All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 61 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 62 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 63 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 64 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 65 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007 66 - - - -- Human and Animal Drugs Date Published: 09/10/2009 Notes: All prescription drugs (finished dosage form) - 10/16/2006 Note: On December 1, 2005, a Warning Letter was issued to Samson Medical Technologies for importing and marketing unapproved antibiotic drug products. The products may be offered for entry labeled as ¿sterile bulk¿ and ¿For pharmacy compounding only¿, although the articles are in fact finished pharmaceuticals. Currently Samson does not hold approved applications for all these products. Districts should contact CDER Import-Export Team if they have any questions about the regulatory status of the products. Note changed - 6/5/2007

accessdata.fda.gov, retrieved 2026-09-09

Source

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