Inspections, Compliance, Enforcement, and Criminal Investigations
Injex-Equidyne Systems, Inc. 17-Jul-06
Department of Health and Human Services
Public Health Service
Los Angels District
RETURN RECEIPT REQUESTED
Jim Fukushima, Owner and CEO
HNS International, Inc .
Injex-Equidyne Systems, Inc.
4992 E. Hunter Avenue
Anaheim, CA 92807
Dear Mr. Fukushima:
Your establishment, Injex-Equidyne Systems, Inc. (IES), located in Anaheim, California, was inspected by representatives of the Food and Drug Administration in February and May, 2006. During those inspections our investigators determined that your establishment manufactures Needle Free Injection Systems. Non-electrically powered fluid injectors are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(h)].
The above-stated inspections 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 manufacturing, packing, storage, or installation are not in conformance with the Quality System regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1) The management representative has not ensured that the quality system requirements are effectively established and maintained [21 CFR 820.20(b)(3)(i)]. Specifically,
a. The Management Representative has not reported on the quality system performance to management with executive responsibility.
b. Your firm has failed to conduct management review meetings in accordance with your Management Review procedure, QOP-56-O1.
2) Corrective and preventive action activities have not been documented, including analysis of sources of quality data, investigations of causes of nonconformities,identifying the actions needed to correct or prevent recurrence of nonconforming product and other quality problems, the verification or validation of corrective actions, implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems, dissemination of information about quality problems or nonconforming product to those directly responsible for assuring the quality of such product or the prevention of such problems, and submission of information on quality problems and corrective and preventive actions for management review [21 CFR 820.100(b)]. Specifically,
a. Your firm has failed to implement your CAPA procedure, QOP 85-02.
b. Your firm is aware that the Injex 30 ampoules crack or fracture when injected at the lower dose level. There is no documentation to show how your firm evaluated this problem and the corrective actions taken to prevent or reduce its occurrence. No CAPA was opened for this quality problem.
3) Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements were not implemented [21 CFR 820.50]. Specifically,
a. Your firm has not qualified suppliers and failed to continuously monitor each supplier's performance in accordance with your procedure, QOP 74-O1.
b. Your firm does not maintain a list of qualified suppliers, contractors or consultants.
c. The Supplier Evaluation Procedure is inadequate in that it allows suppliers such as consultants who have worked for the Company at least six months to be exempt from an initial supplier evaluation.
4) Procedures for the control and distribution of finished devices have not been established to ensure that only devices approved for release are distributed [21 CFR 820.160(a)]. Specifically,
a. Your firm has no procedures for control and distribution of product stored in the warehouse. No procedure has been established to ensure that expired or deteriorated devices are not distributed.
b. Your firm failed to implement the Returned Material Authorization Procedure, QOP 82-06, for returned devices from asset sales and/or customer returns. No records are kept for devices returned as a result of a customer complaint.
c. No records are kept for products returned back to stock or inventory and whether or not an evaluation or inspection was conducted to determine if the device continues to meet specifications such as sterility. For example
Sale Invoice numbers [redacted] and [redacted] show devices were sold and shipped to customers with expired sterility.
5) Complaint handling procedures for receiving, reviewing, and evaluating complaints have not been documented and implemented [21 CFR 820.198(a)). Specifically,
a. Your firm failed to implement the Customer Complaint procedure, QOP 72-03.
b. Your firm is not recording complaints upon receipt. Records are not being kept by your firm as per your complaint procedure, QOP 72-03.
c. Records of complaint investigations do not include the address and phone number of the complainant.
d. Records of complaint investigations do not include any reply to the complainant.
e. Records of complaint investigations do not include the lot number of the finished device.
f. Complaints stating the failure of the device was due to a design problem were not evaluated to determine if the device should be recalled, for example, complaint numbers OS-006 and 009.
6) Complaint handling procedures have not been implemented to ensure that all complaints are evaluated to determine whether the complaint should be filed as a Medical Device Report [21 CFR 820.198(a)(3)]. Specifically,
a. Complaints involving a device failure have not been evaluated to determine whether the complaint should be filed as a Medical Device Report.
b. Complaints reporting a device malfunction such as pain or bruising and failures such as "wet shots" have not been evaluated to determine if a serious injury occurred, for example, complaint numbers OS-001 and OS- 002.
7) Procedures for planning and conducting reviews of the design results at appropriate stages of the device's design development were not implemented [21 CFR 820.30(e)]. Specifically,
a. Design reviews have not been conducted for the IES Injex 50 system project.
b. Design changes were made to the IES Injex 50 system project after 8/1/O5. No design reviews were conducted for these changes. No documentation exists to indicate why these changes were made and if the changes relate to quality issues or the performance of the device.
c . The [redacted] results for depth of penetration reported for the IES Injex 50 Injector project could not be substantiated by raw data, photographs or other documentation. No raw data exists for this test or the associated comparison test results.
d. Your firm did not write a protocol for validating the stated ampoule volume/dose measurements for the IES Injex 50 project. A Dose Accuracy Verification study was conducted but no raw data exists to substantiate the results. The verification test results are listed in a table but it is unknown how this test was conducted, who conducted the test, the ampoule lot numbers or the equipment used.
e. The acceptance criteria for the number of ampoule discharges for the IES Injex 50 project is at least [redacted] discharges without loss of function or catastrophic failure. A test was conducted and shows that [redacted] out of [redacted] injections using the IES Injex 50 injector and ampoule resulted in a catastrophic failure. The Technical Report conclusions for this test state that none of the ampoules lost function or resulted in a failure and no review was conducted.
f. No calibration or operational qualification records exist for the [redacted] test equipment used to verify the spring (tension) force data for the IES Injex 50 project.
8) Quality audits were not conducted at sufficient regular intervals, as prescribed by internal procedures to verify that the quality system is effective in fulfilling your quality system objectives [21 CFR 820.22]. Specifically, your firm has failed to conduct Quality Audits in accordance with its procedure QOP-82-02. In fact, there is no record your firm ever conducted an internal quality audit.
9) Employee training is not documented [21 CFR 820.25(b)]. Specifically, your firm failed to implement its training procedure, QOP 62-01
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and 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 the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.
We acknowledge receipt of your March 10, 2006 response letter to the February FDA- 483. Your response was not adequate. Specifically,
You only claim to be a distributor of the Equidyne Systems Injex 30 Systems and do not recognize your responsibilities as a device manufacturer. Your firm performed manufacturing functions, for example, when it contracted for the assembly, packaging, and sterilization of ampoules from components and contracted for studies to be performed to support extension of expiration dates of sterile accessories.
You did not provide documentation of effective corrective actions. Both inspections revealed multiple instances of missing data or files. For example, your response indicated that the design history file for the Injex 50 device was available for review, yet when our investigator reviewed the file during the May 2006 inspection, it was still incomplete.
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 Quality System/GMP deficiencies are reasonably related will be cleared or approved until the violations have been 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 also be advised that the option to export devices discussed in this letter may be prevented by Sections 801(e)(1) and 802 of the Act [21 U.S.C. §§ 381 and 382]. Adulterated devices may be exported under Section 801(e)(1) if certain conditions are met. One of the conditions [801(e)(1)(D)] is that the device "is not sold or offered for sale in domestic commerce." The Injex 30 injector and accessories have been sold in domestic commerce. Under Section 802, certain unapproved devices may be exported if the conditions of Section 802, as well as Section 801(e)(1), have been met. One condition in Section 802 is that the product be manufactured in substantial compliance with Good Manufacturing Practices.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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 penalties.
Please notify this office in writing within 15-working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify a.nd make corrections to any underlying systems problems necessary to assure that similar violations will not recur. 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 John J. Stamp, Compliance Officer, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612.
Alonza E. Cruse, Director
Los Angeles District