Inspections, Compliance, Enforcement, and Criminal Investigations
Samson Medical Technologies, Inc. 01-Dec-05
Department of Health and Human Services
Public Health Service
New Jersey District
Telephone (973) 526-6004
December 1, 2005
RETURN RECEIPT REQUESTED
Chief Executive Officer
Samson Medical Technologies, Inc.
2050 Springdale Road
Cherry Hill, NJ 08003
FILE NO,: 06-NWJ-08
Dear Mr. Samson:
The U.S. Food and Drug Administration (FDA) conducted an inspection of Samson Medical Technologies, Inc., from May 24 through June 3, 2005. The inspection revealed that your firm is importing and marketing six antibiotic drug products marketed in unit pouches: Cefazolin For Injection, USP 300g and 100g, Cefoxitin For Injection, USP 100g, Nafcillin For Injection, USP 200g, Cefuroxime For Injection, USP 75g and 225g.
The inspection found that these products are labeled as "sterile bulk" and "for pharmacy compounding use only." We have reviewed the labeling and use of these products and have determined that these products are finished pharmaceuticals. These products are not intended for use in compounding but, rather, are intended to be reconstituted per their labeling to achieve a pre-determined concentration and volume, which is then apportioned in IV bags for dispensing to patients in a hospital setting.
These products are drugs within the meaning of Section 201(g) of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. § 321(g)), because they are intended for use in the cure and treatment of disease in man. These products are also new drugs as defined in section 201(p) of the Act (21 U.S.C. § 321(p)), because they are not generally recognized as safe and effective for their labeled use.
Section 505(a) of the Act (21 U.S.C. § 355(a)), requires that any new drug be the subject of an FDA-approved application before it is introduced into interstate commerce. There are no approved applications on file with FDA for the identified products. The marketing of these products without approved applications violates section 505(a) of the Act, and is prohibited by section 301(d) of the Act (21 U.S.C. § 321(d)). Although we note that you have filed ANDA 65-141 for Cefazolin for Injection, 100g and 300g, and ANDA 65-251 for Cefuroxime for Injection, 75g and 225g, these products and the Cefoxitin and Nafcillin drug products are unapproved new drugs and may not be marketed until the applications for these products are approved.
Furthermore, these products are misbranded under section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)), because they do not bear adequate directions for their use. These products are not exempt from this requirement under 21 CFR § 201.115. Please note, under section 301(a) of the Act (21 U.S.C. § 331(a)), the introduction or delivery for introduction into interstate commerce of any drug that is misbranded is prohibited.
The violations described in this letter are not intended to be an all-inclusive list of deficiencies. You should take prompt action to correct the above-referenced violations. Failure to correct the referenced violations may result in regulatory action without further notice. These actions include, but are not limited to, seizure and/or injunction . Federal agencies are routinely advised of the issuance of all warning letters pertaining to drugs so that they may take this information into account when awarding contracts.
Please notify this office in writing within fifteen working days of receipt of this letter, describing the specific actions that you will take, or have taken, to correct the violations. Your response should include an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which corrections will be complete.
Your response to this letter should be directed to the attention of Compliance Officer Andrew Ciaccia, Food and Drug Administration, New Jersey District Office, 10 Waterview Blvd, 3rd Floor, Parsippany, New Jersey 07054.
Douglas I. Ellsworth
New Jersey District Office