Inspections, Compliance, Enforcement, and Criminal Investigations
Adamis Pharmaceuticals 6/9/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Silver Spring, MD 20993|
June 9, 2010
Dennis J. Carlo, PhD, President and CEO
2658 Del Mar Heights Road, #555
Del Mar, CA 92014
Product: Epinephrine Injection 1:1000
Dear Dr. Carlo:
This letter is written in reference to your firm’s marketing of unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Based on the information your firm submitted to FDA's Drug Registration and Listing System, you market the following prescription drug: Epinephrine Injection 1:1000 (0.3 mg prefilled single dose syringe).
As labeled, the above product is a drug within the meaning of section 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and because it is intended to affect the structure or function of the body. Further, this drug product, as marketed by your firm, is a "new drug" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the product. Based upon our information, there is no FDA-approved application on file for the above product. The marketing of this product, or other applicable products, without an approved application constitutes a violation of these provisions of the Act.
Additionally, because the above product is intended for conditions that are not amenable to self diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for it so that a layman can use this product safely for its intended uses. Consequently, its labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Because your product lacks a required approved application, it is not exempt under 21 C.F.R. § 201.115 from the requirements of section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of this product therefore violates sections 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. In particular, violations cited in this letter are not necessarily limited to drug products manufactured for your firm by (b)(4) and may apply to all drug products that you market without FDA-approved applications. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of Federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other Federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing regarding whether you plan to cease the violative activities described in this letter. Furthermore, please advise this office of your plan for disposition of any current inventory and what actions you will take to address product that you have already distributed. If you no longer market the product referenced in this letter, your response should so indicate, including the reasons that, and the date on which, you ceased marketing this product. Also please note that if you are no longer marketing this product, you must update the Drug Listing files in accordance with 21 C.F.R. 207.30 (a)(2).
Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive this product is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
Your response to this letter should be directed to the attention of Ms. Astrid Lopez-Goldberg, Regulatory Counsel, at the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, WO51 RM 5368, 10903 New Hampshire Avenue, Silver Spring, MD 20993.
Deborah M. Autor, Esq.
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration