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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sorenson Medical, Inc. 04-Sep-07

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

Public Health Service
Food and Drug Administration


Denver District Office
Building 20 - Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
TELEPHONE: 303-236-3000

September 4, 2007



Mr. James Lee Sorenson
Chief Executive Officer
Sorenson Medical, Inc.
1375 West 8040 South
West Jordan, Utah 84088

Ref. # - DEN-07-07

Dear Mr. Sorenson:

During an inspection of your firm located in West Jordan, Utah on October 16 - November 13, 2006, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures ambulatory infusion pumps and accessories. 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 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 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 responses from Mr. Douglas Bueschel, Vice President RA/QA dated April 13, May 7, June 8, July 9, and August 7, 2007, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to you. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

Corrective and preventive action (CAPA) procedures are inadequate in that all activities required under section 21 CFR 820.100, and their results have not been documented, as required by 21 CFR 820.100(b).

For example, our investigator found that as a result of ongoing complaints of leaking cassettes and out of box failures due to occlusion alarms, your firm instituted [redacted] Corrective Action Requests (CARs) between 2003 and 2006, [redacted] Review of these CARs disclosed significant deficiencies including lack of verification or validation data required by your Standard Operating Procedure, "Process Validation", to ensure that such action is effective and does not adversely affect the finished device.

Failure to verify or where appropriate, validate according to 21 CFR 820.75, changes to a specification, method, process or procedure before implementation and to document these activities, as required by 21 CFR 820.70(b).

For example, changes were made to your injection molding patameters for the amblT cassette bottoms without verification or validation. Although you indicated by response letter dated May 7, 2007, [redacted] from the latest response dated August 7, 2007, [redacted] Therefore, we have concerns that you are still running a non-validated molding operation, almost a full year since you discovered a problem with your mold. Your response states that the reason for the delay was a problem with the [redacted] and that you now anticipate completion of the [redacted] As we discussed during our meeting on February 13, 2007, you need to assure that the parts produced from your molding operations meet specifications. It is unclear what actions you are taking to assure that your products are in conformance with your specifications.

Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).

For example, several instances of finished device and in-process test failures were noted upon review of your production records. There was no documentation demonstrating the evaluation of these failures and a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. Examples of such test failures include:

• Lot number [redacted] of amblT cassettes in which initially [redacted]
cassettes experienced a [redacted]
• Lot number [redacted] used in the Performance Qualification of [redacted]

We have not received an adequate response specific to this violation to determine what, if any, actions you have taken to correct these violations.

Failure to establish and maintain procedures for rework, to include retesting and reevaluation of nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2).

For example, our inspection found that your firm reprocesses returned PreSet ambIT pumps and nonconforming amblT printed circuit boards (PCBs). Although your procedure entitled, "amblT Pump Verification' Procedure" addresses the operational steps used to reprocess PreSet amblT pumps, there is no procedure which addresses rework concerning units which fail during the reprocessing operation.

We have not received an adequate response specific to this violation to determine what, if any, actions you have taken to correct these violations.

Failure to establish and maintain procedures to ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803, the Medical Device Reporting (MDR) requirements, as required by 21 CFR 820.198(a)(3).

For example, there was no evidence that customer complaint records (numbers [redacted]) were evaluated by the firm to determine if the event was required to be reported to FDA.

Your response appears adequate and will be evaluated at the next inspection of your facility.

Failure to adequately validate a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a).

For example, the validation of the [redacted] was not conducted in accordance with the established protocol in that a smaller sample size was tested than what was specified in your protocol and required by the ANSI/ASQ Zl.4 -2003 sampling procedure. The PQ passed and there was no mention of this deviation in the PQ summary allowing for a [redacted]

Your response to this observation appears adequate and will be evaluated at the next inspection of your facility.

Our inspection also revealed that your devices are 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 under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803, Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:

Failure to conduct an investigation of each event, as required by 21 CFR 803.50(b)(3). For example, there is no documentation in Customer Complaint Records (CCRs), [redacted] to indicate that your firm investigated the complaint. Using your firm's Decision Tree for CCRs [redacted] it was concluded "No MDR Required." There is no documentation that you evaluated these events, such as inquiring about patient related outcomes, before answering the important question concerning whether the marketed devices may have caused or contributed to an MDR reportable event. In addition, there is no documentation in any of the above listed CCRs to otherwise indicate that your firm did not have to report these events, as required by 21 CFR 803.20(c)(2). You had no information that would allow a person who is qualified to make a medical judgment (e.g. a physician, nurse, risk manager) to reasonably conclude the product did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur [redacted]

Failure to maintain information in your possession or references to information related to the adverse event, including all documentation of your deliberations and decision making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable under 21 CFR Part 803, as required by 21 CFR 803.18(b)(1)(i). For example, FDA's review of the information in CCRs [redacted] revealed a lack of documentation of your firm's decision making process.

Failure to develop, maintain, and implement written MDR procedures to provide for:(1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements; and (2) A standardized review process or procedure for determining when an event meets the criteria for reporting under 21 CFR Part 803, as required by 21 CFR.803.17(a). You failed to develop, maintain and implement such procedures.

Failure to develop, maintain, and implement written MDR procedures for documentation and recordkeeping of the information that was evaluated to determine if an event was reportable, as required by 21 CFR 803.17(b). For example, you did not document and keep a record of the information you evaluated to determine if the events in CCRs [redacted] were reportable.

We are in receipt of your firm's correspondence dated April 13, May 7, June 8, July 9, and August 7, 2007. During our meeting on February 13, we discussed with you and members of your staff concerns and deficiencies with your January 5, 2007 response, especially with regards to some of the most significant observations. Review of the above cited responses found that you have still not addressed all of our concerns.

As you are aware, our inspection revealed deficiencies in many of your firm's quality systems. The above identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by the FDA. The specific violations noted in this letter and in the Form FDA 483 issued at the conclusion of the inspection (a copy of which is included for your information) may be symptomatic of serious underlying problems in your establishment's quality systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action to your quality systems. Continued distribution of violative devices may result in regulatory action without further notice. These actions include, but are not limited to seizure, injunction, and/or civil penalties.

Federal agencies are advised of the issuance of all Warning Letters regarding medical devices so that they may take this information into account when considering the award of contracts.

You should notify this office in writing within 15 working days of receipt of this letter, of any additional steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the correction will be completed.

Your reply should be sent to the Food and Drug Administration, Denver District Office, P.O. Box 25087, Denver, CO 80225-008, Attention: Regina A. Barrell, Compliance Officer. If you have any further questions, please feel free to contact Ms. Barrell at (303) 236-3043.



B. Belinda Collins
District Director