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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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ARJ Medical, Inc.

 

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

Public Health Service
Food and Drug Administration
 555 Windertey Pl., Ste. 200
Maitland, FL 32751

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-10-25

July 16, 2010

Morris Behar, Acting Managing Director
Aaron Behar, Vice President Sales
ARJ Medical, Inc.
209 State Street
Oldsmar, Florida 34677

Dear Messrs. Behar:

During an inspection of your firm located in Oldsmar, Florida on March 8, 2010 through March 9, 2010, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of Urinalysis Reagent Strips. Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321 (h), this product is a medical device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act (21 U.S.C. § 351 (h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received a response from Mr. Aaron Behar, Vice President Sales dated March 15, 2010 concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you, Mr. Aaron Behar. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for implementing corrective and preventive actions, as reqUired by 21 CFR § 820.100(a).

For example, you do not have a written corrective and preventive action procedure.

We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR § 820.100(a) nor have you informed us of any specific plan or provided evidence of immediate corrections and systemic corrective actions.

2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints and failure to maintain complaint files, as required by 21 CFR § 820.198(a).

For example, you do not have a written complaint procedure nor do you maintain complaint files for the complaints, you stated to the FDA investigator, your firm d concerning the Uri-Test 10 Urinalysis Reagent Strips and/or (b)(4) URS-10, 10 Parameter Urine Reagent Strips.

We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR § 820.198(a) nor have you informed us of any specific plan or provided evidence of immediate corrections and systemic corrective actions.

3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR § 820.50

For example, you have no written procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR § 820.50 nor have you informed us of any specific plan or provide evidence of immediate corrections and systemic corrective actions.

4. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR § 820.30)a)(1).

For example, you have no written design control procedures to control the design of the Uri-Test 10 Urinalysis Reagent Strips and/or (b)(4) URS-10, 10 Parameter Urine Reagent Strips including not having documentation of requirements for the labeling of the products

We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR § 820.30(a)(1) nor have you informed us of any specific plan or provide evidence of immediate corrections and systemic corrective actions.

5. Failure to establish a quality policy and objective for, and commitment to, quality and for management with executive responsibility to ensure that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR § 820.20(a).

For example, during the March 8 through 9, 2010 inspection of ARJ Medical, you stated to the FDA investigator that the quality policy and quality objectives for producing the Uri-Test 10 Urinalysis Reagent Strips and/or (b)(4) URS-10, 10 Parameter Urine Reagent Strips have not been define, documented, and implemented.

We have reviewed your response and have concluded that it is inadequate. Your firm has not adequately addressed the requirements of 21 CFR § 820.20(a) nor have you informed us of any specific plan or provided evidence of immediate corrections and systemic corrective actions.

This inspection also revealed that your device is misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act. 21 U.S.C. 360i. and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:

Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR § 803.17

For example, during the March 8 through 9, 2010 inspection of ARJ Medical, you stated to the FDA investigator that your firm lacks written MDR procedures.

We have reviewed your response and have concluded that it is inadequate because you have not addressed the regulatory requirements to develop, maintain and implement written MDR procedures.

Although not discussed during the inspection of your firm on March 8-9 2010, the FDA has learned that your firm is marketing the Sure Response Pregnancy Test and Quick Response Drug Screen, in the United States (U.S.) without marketing clearance or approval, in violation of the Act. We reviewed your web site at the Internet address http://www.arjmedical.com for the Sure Response Pregnancy Test and Quick Response Drug Screen. The products are devices within the meaning of Section 201 (h) of the Act.

The Sure Response Pregnancy Test and Quick Response Drug Screen are adulterated under section 501(f)(1)(8) of the Act, 21 U.S.C. 351(f)(1)(8), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(0) of the Act, 21 U.S.C. 352(0), in that the devices were manufactured, prepared, propagated, compounded or processed in an establishment not duly registered under section 510,21 U.S.C. 360, was not included in a list required by 510(j), 21 U.S.C. 360(j) and a notice or other information respecting the devices was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k). Again, for a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81 (b). Again, the kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Salvatore N. Randazzo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Mr. Randazzo at (407) 475-4712.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.

Sincerely yours,
/S/
Emma R. Singleton
Director, Florida District