| Public Health Service Food and Drug Administration |
Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612 Phone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
November 17, 2011 W/L 11-12
Mr. Eric S. Glader, President & CEO
Crescendo Therapeutics LLC
2875 Scott Street, Suite #104
Vista, CA 92081-8559
Dear Mr. Glader:
During our April 20 to 28, 2011 inspection of your pharmaceutical distributing facility, Crescendo Therapeutics LLC, located at 2875 Scott St., Suite #104, Vista, CA 92081-8559, an investigator from the Food and Drug Administration (FDA or Agency) identified significant violations of the Post-Marketing Adverse Drug Experience (PADE) regulations, Title 21, Code of Federal Regulations (21 CFR), Part 310.305. In addition, your firm has violated Sections 505(a) and 502(f)(l) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 355(a) and 352(f)(1)] because you have introduced into interstate commerce an unapproved new drug, which is also misbranded. The introduction or delivery for introduction into interstate commerce of this misbranded product without an approved new drug application violates Section 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].
We have reviewed your firm’s response to the form FDA 483, dated May 13, 2011. Your response is insufficient because it lacks sufficient details about your corrective actions.
Specific violations observed during the inspection include, but are not limited to, the following:
PADE Violations
Your firm is in violation of 21 CFR 310.305(a), which requires a distributor of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA.
Specifically, your firm does not have written procedures in place for the surveillance, receipt, evaluation, and reporting to FDA of adverse drug experiences pertaining to the drug HybriSil (methylprednisolone acetate 1% in silicone gel).
During the inspection of your firm, management stated that they had not received any quality complaints or adverse drug experiences “so far.” Regardless, under FDA regulations you are still required to have written procedures in place to ensure that adverse drug experiences are correctly identified, assessed, and reported to FDA.
In your response to the form FDA 483, you stated that “Crescendo has finalized a written procedure for the surveillance, receipt, evaluation and reporting to FDA of post-marketing adverse drug experiences,” but your firm did not provide a copy of this finalized procedure. Therefore, the Agency cannot evaluate the adequacy of your proposed corrective action, and we find your response to this violation inadequate.
Unapproved New Drug and Misbranding Violations
In addition to violating PADE regulations at your facility, you have also violated the Act by distributing an unapproved new drug, HybriSil. As labeled, this 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 distributed 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 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)(l) 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) and (d) of the Act [21 U.S.C. §§ 331(a) and (d))]. You should discontinue distributing this violative product, as well as any other unapproved drugs at your facility.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance 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. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed.
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 and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Additionally, your response should state if you no longer distribute the drug product, and provide the date(s) you ceased distribution. For discontinued products, you must update the Drug Listing files in accordance with 21 C.F.R. § 207.30(a)(2).
If you have any questions about the content of this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918.
Your reply should be sent to the following address:
Food and Drug Administration
Attention: Blake Bevill, Director Compliance Branch
19701 Fairchild
Irvine, California 92612-2445
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
cc:
Ingeborg Small, Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Ave. – MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413
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