Attention: Mr.

VIA UNITED PARCEL SERVICE

Attention: Mr. John Houghton, President

41 Grand Avenue, Suite 201

River Edge, New Jersey 07661-1947

During an inspection of your firm

located in River Edge, New Jersey, on October 08, 2014 through October 24, 2014, an investigator from the United States Food and

Drug Administration (FDA) determined that your firm manufactures medical devices including, but not limited to: Dual Stage Ultrafilter

(DSU); Single Stage Ultrafilter (SSU); OLpur H2H Hemodiafiltration System; and OLpur Mid-Dilution Series Hemodiafiltration System.

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.

The inspection revealed that the

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

We received your written responses,

dated November 13, 2014 and December 11, 2014; and responses from Mr. Greg Collins, Vice President R&D, dated January 9, 2015

and January 22, 2015, concerning our investigator's observations noted on the Form FDA 483, Inspectional Observations, issued

to your firm on October 24, 2014.

We address these responses below,

in relation to each of the noted violations. These violations include, but are not limited to, the following:

For example, your firm

evaluated potential suppliers based on a designated supplier type related to the services and/or products provided. Review of

your vendor list found that not all suppliers had questionnaires completed and/or a quality agreement in order that your firm

is made aware of changes to products and/or services. Quality oversight of your suppliers will ensure that your firm is made aware

of changes which may affect the quality of the finished device. Examples of active suppliers who had not been adequately evaluated

included a supplier used for sterilization of your finished devices and suppliers of dialyzers and dialysis equipment.

It should also be noted

that deficiencies in purchasing controls had also been observed during the previous inspection of your firm.

We reviewed your firm's responses

and conclude that they are not adequate. We acknowledge that your firm created CAPA 13-014, dated 09/06/2014, and CAPA 14-030,

dated 10/27/2014, which included the reduction of your approved supplier list to reflect only those vendors that are actually

involved in the production of your medical devices. You also revised your SOP 7.4, Purchasing and Monitoring/Supplier Monitoring

Controls, dated 01/08/2015, to more clearly define your supplier types. You identified your contract manufacturer as being the

responsible party for sterilization of your medical devices as they contract this service out, therefore, they were removed from

the approved supplier list. Please be advised that as the owner and 510(k) holder of medical devices, your firm is responsible

for oversight of all manufacturing operations and, therefore, has regulatory responsibility for the quality and safety of the

medical devices that you market and distribute.

For example, your SOP

8.2.1, Customer Feedback, Complaint Handling & Monitoring, dated 01/23/2014, Section 9.5, states that the initial investigation

shall be documented on the customer complaint form and, based on the nature of the complaint, must include: evaluation of the

returned product or inventory retention samples; review of in-house device history records; review of shipping records; review

of complaint trends; review of risk controls; and/or review of product labeling. Your complaint investigations were observed to

be inadequate in that they were lacking critical information, as evidenced by the following customer complaints including, but

It should also be noted

that deficiencies in complaint handling had also been observed during the previous inspection of your firm.

We reviewed your firm's responses

and conclude that the adequacy of your responses cannot be determined at this time. Your responses stated that you initiated CAPA

14-020, dated October 26, 2014, and CAPA 14-029, dated 10/27/2014, in order to improve the complaint handling process. Your firm

also revised SOP 8.2.1, Customer Feedback, Complaint Handling & Monitoring, dated 11/11/2014, and the Customer Feedback/Complaint

Form F-8.2, which requires that there shall not be any unaddressed sections or blank fields on the complaint form. Additionally,

your responses stated that you conducted a retrospective review of all 2013 and 2014 complaints to ensure forms were completed.

Your response includes the complaint numbers reviewed, but failed to include the actual customer complaint files, in order to

provide supporting evidence that your complaint files were updated. We will review your revised procedures and ensure that they

are implemented in addition to verifying that all complaint files/investigations include critical information, during the next

FDA also noted nonconformances with

section 502(t)(2) of the Act [21 U.S.C. 352(t)(2)], which are deficiencies pertaining to the Medical Device Reporting (MDR)

Regulation found at Title 21, Code of Federal Regulations (CFR), Part 803. These nonconformances include, but are not limited

1. Failure to include

the following information in your firm's reports, if known or reasonably known to your firm, as described in 21 CFR 803.50(b).

This type of information corresponds generally to the format of FDA Form 3500A: "Date of event," (Form 3500A, Block

3B), as required by 21 CFR 803.52(b)(3).

Specifically, your firm

submitted 33 MDRs to the FDA that did not identify the "Date of event" in Block B3 of the FDA Form 3500A. In addition,

your firm did not include in Block H11 - "Corrected data", of the associated 3500A forms, an explanation of why

the required information was not provided and the steps taken to obtain such information.

We acknowledge that your response,

dated November 13, 2014, states that you had submitted 33 supplemental MedWatch reports to CDRH's MDR Policy Branch on November

12, 2014. However, your response, dated December 11, 2014, is not adequate. Your firm submitted a revised MDR procedure titled"

"US-MDR, EU-MVR, Canada-MPR, Advisory Notices & Recalls", SOP 806, Rev B, dated December 4, 2014. Although the revised

procedure includes instructions for completing the FDA Form 3500A, the following additional issues need to be addressed:

(1) "US-MDR, EU-MVR, Canada-MPR,

Advisory Notices & Recalls", SOP 806, does not establish internal systems that provide for timely and effective identification,

communication, and evaluation of events that may be subject to MDR requirements. For example:

procedure omits the definition of the term "reasonably suggests," found in 21 CFR 803.20(c)(1). The exclusion of the

definition for this term from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint

that may meet the criteria for reporting under 21 CFR 803.50(a).

(2) "US-MDR, EU-MVR, Canada-MPR,

Advisory Notices & Recalls", SOP 806, does not establish internal systems that provide for timely transmission of complete

medical device reports.

Specifically, the following is not

a. The procedure does

not include the address for where to submit MDR reports as follows:

FDA, CDRH, Medical Device Reporting,

P.O. Box 3002, Rockville, MD 20847-3002.

(3) "US-MDR, EU-MVR, Canada-MPR,

Advisory Notices & Recalls", SOP 806, does not describe how your firm will address documentation and record-keeping requirements,

adverse event related information maintained as MDR event files.

was evaluated to determine if an event was reportable.

of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction

was or was not reportable.

The eMDR Final Rule requiring manufacturers

and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements

of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage

you to visit the following web link for additional information about the electronic reporting requirements: