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U.S. Department of Health and Human Services

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Enforcement Actions

Creative Medical Corporation

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 San Juan District
Compliance Branch
466 Fernandez Juncos Avenue
San Juan, Puerto Rico 00901·3223
Telephone: 787-474-9500
FAX: 787-729-6658
 

May 5, 2006
 

WARNING LETTER
SJN-06-08

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Saleh Yassin
President & Chairman of the Board
Creative Medical Corporation
Box 29166, 65 Infanteria Station
Rio Piedras, Puerto Rico 00929-9166

Dear Mr. Yassin:

This Warning Letter is in reference to the inspection of your facility, located at road number 172, kilometer 9.4, Bayamoncito sector, Cidra, Puerto Rico 00739, from October 31, 2005, to December 6, 2005, by an Investigator from the U.S. Food and Drug Administration's San Juan District Office.

During the inspection, the Investigator collected labeling specimens for products identified below that are manufactured and distributed by your firm. These products include a dietary supplement and various over-the-counter (OTC) drug products that are intended for use as cough/cold preparations. Products that are offered for the cure, mitigation, treatment, or prevention of cough/colds are drugs as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 321(g)(1)). The OTC cough/cold preparations are also subject to final rules in Title 21 Code of Federal Regulations (21 C.F.R) Part 341 that set forth acceptable labeling and formulation conditions for OTC drugs. Our review of the labeling and formulations for these OTC cough/cold preparations revealed violations of the Act and regulations as follows:

OTC Drug Products:

1. 7 Jarabes Children's Bubble Gum Flavor (labeled in English) and Formula Original 7 Jarabes (labeled in Spanish) each claim to be an expectorant and each contains ipecac fluid extract ("extracto fluido de ipecacuana") as the active ingredient. Based on the claims as a demulcent and expectorant, the products are as defined in section 201(g) of the Act (21 U.S.C. § 321(g)) and subject to the final rules covering cough/cold preparations at 21 C.F.R. Part 341.

Ipecac fluid extract is not an acceptable active ingredient for an expectorant indication (21 C.F.R. § 341.18). Further, there are no provisions in the cough/cold regulations for demulcent claim for the ingredient. Because ipecac fluid extract is not generally recognized as safe and effective for expectorant or demulcent use, the products are new drugs as defined in section 201(p) of the Act (21 U.S.C. § 321(p)). new drug may not be legally marketed in this country unless it has an approved application pursuant to section 505 of the Act (21 U.S.C. § 355).

2. Jarabe Tolu (labeled in Spanish) contain (b)(4) and claims to be a demulcent for simple colds ("demulcente en catarros simples"). Based on the claims as a demulcent for use in simple colds, the product is a drug as defined in section 201(g) of the Act (21 U.S.C. § 321 (g)) and is subject to the final rules covering cough/cold preparations at 21 C.P.R. Part 341.

(b)(4) is not an acceptable active ingredient for use as a demulcent for the relief of simple colds under the final regulations for OTC cough/cold drugs at 21 C.F.R. Part 341. Therefore, the product is a new drug as defined in section 201(p) of the Act (21 U.S.C. § 321(p)). A new drug may not be legally marketed in this country unless it has an approved application pursuant to section 505 of the Act (21 U.S.C. § 355).

3. 7 Jarabes DM (labeled in Spanish) is an antitussive (cough suppressant) and contains (b)(4) as the active ingredient. Based on the labeled claims such as "Supresor de la tos" (cough suppressant) and "alivio temporero ala tos causada por el catarro comun" (for the temporary relief of cough caused by the common cold), the product is a drug as defined in section 201(g) of the Act (21 U.S.C. § 321(g)) and is subject to the final rules that cover cough/cold preparations at 21 C.P.R. Part 341.

Over-the-counter antitussive (cough suppressant) drug products must be formulated and labeled in accordance with this final rule in order to be generally recognized as safe and effective and not misbranded. The product does not comply with the final rule in that the label for 7 Jarabes DM fails to bear the "cough suppressant" statement of identity on the principal display panel as required 21 C.F.R. § 201.61(a) and 21 C.F.R. § 341.74(a). The label also fails to bear the established name of the drug, dextromethorphan hydrobromide oral solution, on the principal display as required by 21 C.F.R. § 201.61(b).

Based on the violations cited above, the product is misbranded under section 502(a) of the Act (21 U.S.C § 352(a)).

4. 7 Jarabes CA is labeled (in English) as an antihistamine, antitussive (cough suppressant), and nasal decongestant and contains (b)(4) and (b)(4) in (b)(4).  Based on these claims, the product is a drug as defined in section 201(g) of the Act (21 U.S.C § 321 (g)) and is subject to the final rules that cover cough/cold products 21 C.F.R. Part 341.

The product fails to comply with the final rules in that it fails to bear the following warnings or other required information:

"May cause excitability especially in children." 21 CFR § 341.72 (c)(1)

"Do not take this product, unless directed by a doctor, if you have breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland." 21 CFR § 341.72 (c)(2)

"May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery." 21 C.F.R. § 341.72(c)(3)

"Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor." 21 C.P.R. 341.74(c)(2)

"Do not exceed recommended dosage. [First sentence in boldface type] If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor." 21 C.F.R. § 341.80(c)(1)(A)

"Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor." 21 C.F.R. 341.80(c)(1)(C)

The label fails to conspicuously declare on the principal display panel the percentage of alcohol present in the product. 21 CFR § 328.50.

The label fails to bear the "antihistamine"/"cough suppressant"/"nasal decongestant" statement of identity on the principal display panel as required by 21 C.F.R. § 201.61(a) and 21 C.F.R. 341.72(a), 21 C.F.R. 341.74(a), and 21 C.F.R. § 341.80(a).

Based on the above, the product is misbranded under section 502(f)(2) of the Act (21 U.S.C. § 352(1)(2)) because it fails to bear the complete warnings cited above. The product is further misbranded under section 502(a) of the Act
(21 U.S.C. § 352(a)) because it fails to declare the percentage of alcohol and the required statement of identity on the principal display panel.

5. 7 Jarabes Honey is labeled (in English) an antitussive (cough suppressant), antihistamine, and expectorant and contains (b)(4) and (b)(4).  Based on these claims, the product is a drug as defined in section 201(g) of the Act (21 U.S.C. § 321(g)) and it is subject to the final rules on cough/cold preparations at 21 C.F.R. Part 341.

The combination of an (b)(4) with an (b)(4) is not permitted under the combination section of the final rule on cough/cold preparations (21 C.F.R. § 341.40). Because this combination of ingredients is not permitted, the product is not generally recognized as safe and effective for its intended use. Therefore, the product is a new drug as defined in section 201(p) of the Act (21 U.S.C. § 321(p)). A new drug may not be legally marketed in this country unless it has an approved application pursuant to section 505 of the Act (21 U.S.C. § 355).

6. 7 Jarabes DA is labeled (in English) an antitussive (cough suppressant) and nasal decongestant and contains (b)(4) and (b)(4) Based on these claims, the product is a drug as defined in section 201(g) of the Act (21 U.S.C. § 321(g)), and it is subject to the final rules on cough/cold preparations at 21 C.F.R. Part 341. Over-the-counter antitussive (cough suppressant) and nasal decongestant drug products must be formulated and labeled in accordance with this final rule in order to be generally recognized as safe and effective and not misbranded. Your product fails to comply with the final monograph and other regulations, as follows:

The label fails to bear the "cough suppressant"/"nasal decongestant" statement of identity on the principal display panel required by 21 C.F.R. § 201.61(a) and 21 C.F.R. § 341.72(a), 21 C.F.R. § 341.74(a), and 21 C.F.R. § 341.80(a).

The label fails to bear the warning statement (in boldface type) "Do not exceed recommended dosage" required by 21 C.F.R. § 341.80(c)(1).

The label fails to conspicuously declare on the principal display panel the percentage of alcohol present in the product as required by 21 CFR 328.50.

Based on the violations cited above, 7 Jarabes DA is misbranded under section 502(f)(2) of the Act (21 U.S.C. § 352(f)(2) for the failure to bear required warnings. It is also misbranded under section 502(a) of the Act (21 U.S.C. § 352(a)) for the failure to declare the statement of identity and the amount of alcohol on the principal display panel.

7. 7 Jarabes Vapor Balm Extreme Relief is labeled (in English) as a topical nasal decongestant, cough suppressant, and topical analgesic and contains (b)(4) and (b)(4) as the active ingredients. Based on these claims, the product is a drug as defined in section 201 (g) of the Act (21 U.S.C. § 321(g), and it is subject to the final rules on cough/cold preparations at 21 C.F.R. Part 341 because of the claims for nasal congestion and cough suppression. Over-the-counter antitussive (cough suppressant) and nasal decongestant drug products must be formulated and labeled in accordance with this final rule in order to be generally recognized as safe and effective and not misbranded. Your product fails to comply with the final monograph and other regulations, as follows:

Although certain formulations of topically applied (b)(4) and (b)(4) along with (b)(4) are permitted as a cough suppressant, topical (b)(4) and (b)(4) are not permitted for the relief of nasal congestion (see 21 C.F.R. § 341.20, 21 C.F.R. § 341.40, and 21 C.F.R. § 341.85(b)(5)). Because this combination of (b)(4) and (b)(4) is not permitted for nasal decongestion, the product is not generally recognized as safe and effective for its intended use. Further, because the active ingredients in the product do not include (b)(4) oil, the product does not meet the acceptable combination of ingredients for topical cough suppressants. Therefore, the product is a new drug as defined in section 201(p) of the Act (21 U.S.C. § 321(p)). A new drug may not be legally marketed in this country unless it has an approved application pursuant to section 505 of the Act (21 U.S.C. § 355).

Except for sunscreen products and "convenience size" packages, all OTC drug products initially introduced into interstate commerce after May 16, 2005, need to be labeled in accordance with the Drug Facts requirements set forth in 21 C.P.R. § 201.66 ("Drug Facts") (see 69 Fed. Reg. 53801, September 3, 2004, and 67 Fed. Reg. 16304, April 5, 2002). Three of the products cited above, Jarabe Tolu, 7 Jarabe Honey, and 7 Jarabes Vapor Balm Extreme Relief, are not labeled in accordance with Drug Facts. We also note that you manufacture other OTC drug products that are not yet subject to final monographs for a specific drug category (such as (b)(4) and (b)(4) that are also not labeled in compliance with Drug Facts. Failure to label all of these OTC drug products in accordance with Drug Facts causes them to be misbranded under section 502(a) of the Act (21 U.S.C. § 352(a)).

Dietary Supplement product:

Your Extracto de Malta Maltaglobin is misbranded under section 403(i)(2) of the Act [21 § 343(i)(2)] because the product contains ingredients that are not declared by name on the label. For example:

• The product contains a color additive subject to certification, namely FD&C Red No. 40, but does not declare the color additive by name on the product label. Under 21 CFR 101.22(k)(1), color additives subject to certification must be individually declared in the ingredient statement by the name designated in the color additive's listing regulation, this case FD&C Red No. 40 (21 CFR 73.340). This name may be abbreviated to omit the prefix and the term "No." (e.g. "Red 40" instead of "FD&C Red No. 40").
• The label declares the presence of preservatives in the ingredient statement but does not identify the preservatives by name, as required in 21 CFR 101.22(j).

Your Extracto de Malta Maltaglobin, a dietary supplement, is misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5(F)], because the nutrition information on the product label is not provided in the manner required by regulation. For example:

• The Supplement Facts panel declares the percent daily value of iron in the product but does not declare the quantitative amount of iron by weight, required by 21 CFR 101.36(b)(2)(A). The principal display panel states that the product contains (b)(4) however, that ingredient is not declared in either the Supplement Facts panel or in the list of other ingredients (see 21 CFR 101.36(d), 101.4(g)).

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without notice. These actions include, but are not limited to, seizure of your products, injunction of your manufacturing operations, or both.

Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted Violations, including an explanation of each step taken to prevent the recurrence of similar violations. corrective action cannot be completed within 15 working days, please state the reasons for the delay and the timeframe within which the corrections will be completed.

Federal agencies are advised of the issuance of all warning letters to drug manufacturers so that they may take this information into account when considering the award of contracts. Additionally, pending NDA, ANDA, or export certificate requests may not be approved until the above violations are corrected.

In addition to the violations described above, we have two comments on the label for your Extracto de Malta Maltaglobin dietary supplement product. First, the label declares the product's net quantity of contents in milliliters only. As stated in 21 CFR 101.105(b)(2), statements of fluid measure must be declared in units of U.S. gallons, and quart, pint, and fluid ounce subdivisions thereof. In addition, the product label includes a National Drug Code (NDC) number. For your information, NDC numbers are intended for uniquely identifying drugs and should not be used in dietary supplement labeling. The presence of an NDC number on a product that is not a drug may be a false or misleading representation that misbrands the product under 21 U.S.C. 343(a)(1).

We acknowledge the receipt of your letter dated December 27, 2005, in response to the Current Good Manufacturing Practices (CGMP) observations listed on the FDA-483 form issued to (b)(6) Operation Manager. The inspection found deviations from CGMP, including recurrent deviations from the CGMP requirements for drugs, at your firm. You had previously promised and failed to correct these deviations. Your corrective action plan will be evaluated taking into consideration the inspectional history of your firm during our next inspection of your firm.

Direct your written reply to this letter to the Food and Drug Administration, attention: Carlos Medina, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Medina at (787) 474-9538, carlosa.medina@fda.hhs.gov. You can also find the Act, regulations, and guidelines through links in FDA's Internet homepage at http://www.fda.gov.
 

Sincerely,
/S/
Maridalia Torres
Acting District Director