| Public Health Service Food and Drug Administration |
10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 973-331-4902 |
Department of Health and Human Services
February 18, 2010
WARNING LETTER
HAND DELIVERED
Mr. Steven Squashic, President
Vertical Pharmaceuticals, Inc.
2400 Main Street
Sayreville, NJ 08817
10-NWJ-05
Dear Mr. Squashic:
On (b)(4) FDA issued a warning letter to (b)(4) (copy attached). As explained more fully in that warning letter, certain drug products that (b)(4) has manufactured are new drugs that lack approved applications as required under the Federal Food, Drug and Cosmetic Act (the Act). Based on information obtained during FDA's inspection of (b)(4) your firm contracted or otherwise arranged with (b)(4) to manufacture on or more drug products that your firm distributes. These drug products include, but are not necessarily limited to:
• (b)(4)
The above product is a drug within the meaning of section 201(g) of the Act, [21 U.S.C. § 321(g)] because, as demonstrated by its labeling, it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, it 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 use under the conditions prescribed, recommended, or suggested in its labeling. Under section 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(a), (d) and 355(a)], a new drug may not be introduced into 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 drug. Based on our information, there are no FDA-approved applications on file for this drug product.
Additionally, because the above prescription drug product is intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioner, adequate directions cannot be written for it so that a layman can use these products safely for their intended uses, described in 21 C.F.R. § 201.5. Consequently, the 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 the product lacks the required an 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 without approved new drug applications violates section 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].
Further, as explained in the warning letter dated (b)(4) the above drug product is adulterated, 21 U.S.C. 351(a)(2)(B), and thus your firm may not introduce or deliver them for introduction into interstate commerce, 21 U.S.C. § 331(a).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. In particular, violations cited in this letter are not necessarily limited to drug products manufactured 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 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer market the above product, your response should so indicate, including the reasons that, and the date.on which, you ceased production.
Your reply should be sent to Nancy Rolli, Director of Compliance at the Food and Drug Administration, 10 Waterview Boulevard, Parsippany, NJ 07054.
Sincerely,
/S/
Diana Amador-Toro
New Jersey District Director
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