WARNING LETTER
Creative Science, Inc.
MARCS-CMS 554119 —
May 23, 2018
Product:
Animal & Veterinary
Recipient:
Recipient Name
Bradley H. Butler
Creative Science, Inc.
455 Sovereign Ct.
Ballwin
,
MO
63011
United States
Issuing Office:
Detroit District Office
United States
Division
of Pharmaceutical Quality Operations III
300 River Place, Suite 5900
Detroit, MI
48207
Telephone: (313)
393-8100
Fax: (313)
393-8139
May
23, 2018
WARNING LETTER
Case# 554119
UPS
NEXT DAY
SIGNATURE REQUIRED
Bradley H. Butler
President/CEO
Creative Science, Inc.
455 Sovereign Ct.
Ballwin, MO 63011
Dear Mr. Butler:
The U.S. Food and Drug
Administration (FDA) conducted an animal drug manufacturing inspection of Creative Science, Inc., 455 Sovereign Ct., Ballwin, Missouri, from March 6 to 13, 2017.  In a letter dated November 8, 2017, FDA acknowledged your response letters and stated that we have no objections concerning your proposed corrective actions as it pertains to cGMP violations.
However, we subsequently reviewed your firm’s product
labeling, claims, and marketing materials available at the web address
http://www.creativesciencellc.com/ where you promote and sell your products. This letter concerns your marketing of the
product P-Bloc.
The information available at your website along
with the evidence collected during the March 2017 inspection confirms that you are shipping the P-Bloc product for animal use. For example, your Homepage at
http://www.creativesciencellc.com/ states that
Creative Science “currently provides products to over 12,000 veterinary hospitals” and “Creative Science’s product portfolio provides medical solutions in species ranging from companion to production animals.” Your sales records show that you shipped the P-Bloc product to “
(b)
(4)
”
and “
(b)
(4)
”, among others.
Further, the
P-Bloc label collected during the March 2017 inspection of your firm states “P-Bloc™ sterile aqueous solution is indicated for the temporary relief of symptoms associated with neurological pain.” P-Bloc is a sterile injectable as stated on the product sheet.
From the information gathered, we
have determined that you are marketing a product that is intended for use in the mitigation, treatment, or prevention of disease in animals, which makes this product a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. §
321(g)(1)(B)]. Further, as
discussed below, this product is an unapproved new animal drug and your marketing of this product violates the FD&C Act.
Because P-Bloc is intended to
prevent, mitigate or treat disease in animals, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321(g)(1)(B)]. Moreover, this product is a new animal drug, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.  It is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, the product is unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)].
Product Marketed as a Human Prescription Drug
Section 510(j) of the FD&C
Act [21 U.S.C. § 360(j)] and Part 207 of Title 21 Code of Federal Regulations (CFR) outline the requirements for registration and listing of drug products. The listing for P-Bloc, NDC 53413-752, among other listing information, must include “The drug type (e.g., as applicable, finished vs. unfinished, human vs. animal, prescription vs. nonprescription)”. See 21 CFR § 207.49(a)(8).
A
review of the listing for P-Bloc, NDC 53413-752, revealed that the listing for this product includes inaccurate information.  P-Bloc, NDC 53413-752, is identified through its drug listing file submitted to FDA as a “Human Prescription Drug” while information that your firm provided FDA during inspection of your facility in March 2017 indicates that P-Bloc, NDC 53413-752, is for “animal use only”. As a result, your product’s listing data has been removed from the FDA’s online NDC Directory. This is an effort to maintain an accurate database in order to protect and promote the public health. Any question on drug listing requirements can be sent to FDA’s Drug Registration and Listing Staff at
eDRLS@fda.hhs.gov.
This letter is not intended to be an
all-inclusive review of your products.  It is your responsibility to ensure that all of your products are in compliance with the FD&C Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice.  Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
You should notify
this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law.  Your response should include any documentation necessary to show that correction has been achieved.  If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed.  Include copies of any available documentation demonstrating that corrections have been made.
Please send your electronic reply
to: ORAPHARM3_RESPONSES@fda.hhs.gov.
Attn:
Brian
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Art O. Czabaniuk
Prograin Division Director
Division of Phannaceutical Quality Operations III
Content current as of:
06/05/2018
Regulated Product(s)
Animal & Veterinary