Inspections, Compliance, Enforcement, and Criminal Investigations
Sorenson Development, Inc. 17-Oct-01
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. BOX 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
October 17, 2001
RETURN RECEIPT REQUESTED
Ref. #: DEN-02-03
Mr. James Lee Sorenson
Sorenson Development, Inc.
2511 South West Temple
Salt Lake City, Utah 84115
Dear Mr. Sorenson:
On August 22 ? September 4, 2001 Investigator Ricki A. Chass-Off of our office conducted an inspection of Sorenson Medical, Inc., West Jordan, Utah. Our investigator determined that your firm manufactures various products, including infusion pumps. These products are devices as defined by Section201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The above stated inspection revealed that these devices are adulterated within the meaning Section 501 (h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System/Good Manufacturing Practice (QS/GMP) for Medical Devices Regulation, as specified in Title 21, Code of Federal Regulations (21 CFR), Part 820. The deviations are as follows:
1. Failure to provide employees who manage, perform and assess quality with the independence and authority necessary to perform their tasks as requiredby21 CFR 820.20 (b) (l). Specifically, Quality Assurance and Quality Control personnel do not have the authority to stop manufacturing in the event out of specification products are discovered during production.
2. Failure to identify sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems as required by 21 CFR 820.100 (a) (1) specifically, your Corrective Action Report procedure [redacted] fails to define sources of quality data such as rework material, scrapped material, in process failures, finished product failures and engineering change orders.
3. Failure to document acceptance activities to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by21 CFR 820.80(e). Specifically, production lots were released without documented review of results of flare, length and/or post sterilization tests (lots [redacted] through [redacted]).
4. Failure to follow established procedures for finished device acceptance to ensure devices are not released until associated data and documentation are reviewed and the release is authorized as required by 21 CFR 820.80 (d). Specifically, lot [redacted] was released and distributed on 7/17/01, however the device history record was not signed by a QC representative until 7/19/01. Lot [redacted] was released and distributed on 7/31/01 however, the device history record was not signed by a QC representative until 8/10/01.
5. Failure to establish procedures or document rework to ensure the product meets its current approved specifications as required by 21 CFR 820.90 (b) (2). Specifically, there are no written standard operating procedures for nonconforming product rework although these activities are being performed. Additionally, these rework activities are not recorded in the device history record.
6. Failure to validate processes with a high degree of assurance where the results cannot be fully verified by subsequent inspection and testing, and have those processes approved and documented according to established procedures, as required by 21 CFR 820.75 (a).
Specifically, revalidation of the microprocessor software used in the Palm Pump has not been completely performed following an engineering change in April 2001. Additionally, computer and/or automated data processing system software used in production and quality systems, including the use of electronic signatures, has, not been validated.
7. Failure to follow established procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72 (a). Specifically, [redacted] gauges used in the Quality Assurance Laboratory and in production were beyond their calibration dates and in use during the inspection.
8. Failure of management to perform effective reviews to ensure the quality system satisfies the requirements of 21 CFR 820 and the manufacturer?s established quality policy and objectives as required by 21 CFR 820.20 (c). Specifically, management review failed to take appropriate corrective and preventive action to establish authority and independence for Quality Control or to perform computer systems validation, although management was made aware of these deficiencies.
The above-identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that your establishment is in compliance with all requirements of the Federal regulations. The specific violations noted in this letter and in the Form FDA-483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your establishment?s quality system. You are responsible for investigating and determining the causes of tile violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.
We acknowledge receipt of your September 18, 2001 response to the FDA-483. We are unable to evaluate the effectiveness or your response as no supporting documents were included.
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, no premarket submissions for Class III devices to which the QS/GNIP deficiencies are reasonably related will be cleared until the violations are corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by us without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
You should notify this office in writing within fifteen (15) working days of receipt of this letter of any other additional steps you have taken to correct the noted violations and to prevent their recurrence. If corrective action cannot be completed within fifteen (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 H. Tom Warwick, Compliance Officer, Food and Drug Administration, Denver District, P. O. BOX 25087, Denver, CO 80225-0087. If you have any further questions, please feel free to contact Mr. Warwick at (303) 236-3054.Sincerely,
Thomas A. Allison