Genesis BPS, LLC. 6/12/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 331-4906
June 12, 2013
Dr. Jerrold B. Grossman
Genesis BPS, LLC.
65 Commerce Way
Hackensack, NJ 07601
Dear Dr. Grossman:
During an inspection of your firm located in Hackensack, New Jersey from February 4, 2013 through February 11, 2013, an investigator from the United States Food and Drug Administration (FDA) reviewed your records for Pedi-Pak 75 mL Transfer Pack and Pedi-Pak Pedi-Syringe Filter 30 mL, 35 mL & 60 mL sets. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are 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.
Our inspection revealed that the Pedi-Pak 75 mL Transfer Pack and Pedi-Pak Pedi-Syringe Filter 30 mL, 35 mL & 60 mL setsare adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 Pedi-Pak 75 mL Transfer Pack and Pedi-Pak Pedi-Syringe Filter 30 mL, 35 mL & 60 mL sets are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device not notify the agency of its intent to introduce in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k), 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(i). Specifically, you have modified the Pedi-Pak Pedi-Syringe Filter 30 mL, 35 mL and 60 mL, cleared under K050805, and the Pedi-Pak 75 mL Transfer Pack, cleared under BK850003. The following changes or modifications were not included under K050805 and BK850003: 1) Material change from a (b)(4) to DEHP-free (b)(4); and 2) Material changes to BPA-free, Latex-free, and no animal derived materials. These changes represent significant modifications in design, components, method of manufacture, or intended use that could significantly affect the safety or effectiveness of the device and represent a major change or modification in the intended use of the device. For example, changes in the material used as described above could cause harm to the patient if it has not been adequately tested and determined to be safe for patient use. Therefore, these changes or modifications require the submission of a 510(k).
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 C.F.R. 807.81(b). The type of information your firm needs to submit in order to obtain approval or clearance for your device is described on the Internet at the following link:
The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Our inspection also revealed that the labeling for the Pedi-Pak 75 mL Transfer Pack and Pedi-Pak Pedi-Syringe Filter 30 mL, 35mL & 60 mL sets contains statements that these devices are DEHP-free, Latex-free, BPA-free and contain no animal derived materials. As stated in FDA’s “Guidance for Industry and Food and Drug Administration Staff – Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex,” issued on March 11, 2013, statements submitted for inclusion in medical product labeling, such as “latex-free,” “does not contain natural rubber latex,” or “does not contain latex” are not accurate because it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product. Additionally, FDA Guidance, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,” issued on April 23, 2013, states, FDA believes that devices labeled as “DEHP-free,” “BPA-free,” or “pyrogen-free” are not accurate because it is not possible to reliable assure that there is an absence of the allergen or toxin in the medical product. Use of such terms may give users a false sense of security when using a medical product. FDA recommends the use of a statement such as “Not made with BPA” based on material certification to indicate that BPA is not used in the device or device component.
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 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 violations, or similar violations, 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 fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Robert J. Maffei, Compliance Officer, U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054. If you have any questions about the content of this letter, please contact Mr. Maffei via telephone at 973-331-4906 or via fax at 973-331-4969.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your firm’s 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. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.