Inspections, Compliance, Enforcement, and Criminal Investigations
EEMSO, Inc. 30-Mar-06
Department of Health and Human Services
Public Health Service
4040 North Central Expressway
March 30, 2006
RETURNED RECEIPT REQUESTED
Mr. Daniel P. Sheviin, Owner
EEMSO, Inc., (formerly Shevlin Medical, Inc.)
6120 Peeler Street
Dallas, TX 75235
Dear Mr. Shevlin:
On January 24, 31, 2006 and February 1, 16, 2006, the United States Food and Drug Administration (FDA) conducted an inspection of EEMSO, Inc., at the above-referenced address. The FDA investigators determined that your firm acts as a specification developer and an importer for the E-Strip Disposable lontophoretic Treatment System and the High Voltage Galvanic Stimulator (HVGS) Model 9000 and 9000 Il, and an importer for the M2 Series Wireless TENS unit. These products are manufactured, imported, and marketed in the U.S. under your firm's name. These products are devices, as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21. U.S.C. § 321(h)).
Entities performing the functions of specification development or an initial distributor (importer) of medical devices are classified as medical device manufacturers within the meaning of 21 CFR § 820.3(o), and therefore, are subject to the Quality System Regulation, 21 CFR § 820. The FDA's inspection revealed that your devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C. § 351(h)) because the methods used in, or the facilities or controls used for the manufacturing, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Your devices are also misbranded within the meaning of Section 502(t)(2) of the Act (21 U.S.C.§ 352(t)(2)) because your firm failed to establish and maintain adequate written medical device reporting (MDR) procedures, as required by Section 519 of the Act (21 U.S.C. § 360i) and the MDR Regulation, 21 CFR Part 803.
Your devices are further misbranded within the meaning of Section 502(o) of the Act (21 U.S.C. § 352(o)) because your firm failed to submit a device listing for the E-Strip Disposable lontophoretic Treatment System as required by Section 5900 of the Act (21 U.S.C. § 360j) and the Device Listing Regulation, 21 CFR Part 807.
The FDA documented these significant violations of the QS, MDR, and Device Listing regulations and is seriously concerned about your failure to comply with the Act and FDA regulations. At the close of the inspection an February 23, 2006, FDA issued to you a list of Inspectional Observations, Form FDA-483, which identifies a number of significant violations, including, but not limited to, those described below.
1. Failure to maintain and provide all GMP records for FDA's inspection, as required by 21 CFR § 820.180. [FDA-483 Item 1]. The FDA investigators had pre-announced the routine inspection, arranged suitable inspection times and dates to accommodate your personal schedule, and met you at the inspection site to discuss and afforded you ample opportunity to make your GMP records readily available throughout the current inspection. At the conclusion of the inspection, you failed to provide the design control records, device master records, and distribution records. You asked the FDA investigators to submit a written request to review your design control records. The investigators made a verbal request to review your GMP records, including design control records, to assess your firm's compliance with 21 CFR § 820.
2. Failure to evaluate and select potential suppliers; contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and document the evaluation, as required by 21 CFR§ 820.50(a)(1). [FDA-483 Item 13]. Your firm does not have written purchasing control procedures or documentation that all suppliers have been evaluated and selected on the basis of their ability to meet specified requirements. For example, you stated that your firm developed the design specifications for the E-Strip Disposable lontophoretic Treatment System in 2001, received a cleared 510(k) (K031769] in 2003, and contracted the manufacturing of this device to a foreign broker[redacted] who acted as a middle man who then outsourced the actual device manufacturing to another foreign firm in [redacted]. You stated that you do not know the name of the actual foreign contract manufacturer. You later stated that you had visited the foreign contract manufacturer but that you had no documentation of your visit. Moreover, your firm lacked or failed to provide (a) procedures and records of your design transfer to ensure that the actual identity of the foreign contract manufacturer was documented, and your original device design specifications were correctly translated into actual manufacturing processes at the foreign contract manufacturer. In effect, your devices were manufactured, imported, accepted, and distributed in this country with unknown quality.
3. Failure to- establish and maintain procedures for acceptance or rejection of incoming product, including documentation of the results of acceptance or rejection, as required by 21 CFR § 820.80(b) and (e). [FDA-483 Item 15]. For example, your firm failed to (a) establish written procedures for the inspection, testing, or verification of all incoming devices (e.g. the E-Strip Disposable lontophoretic Treatment System, the High Voltage Galvanic Stimulator (HVGS) Model 9000 and 9000 II, and the M2 Series Wireless TENS unit); and (b) keep the records of your firm's acceptance or rejection of these devices. Receiving acceptance activities also include your firm's receipt of the leased HVGS 9000 and 9000 II devices that were returned to your firm for servicing.
4. Failure to maintain device master records (DMR's) to include or refer to the location of device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and to ensure that each DMR is prepared and approved in accordance with 21 CFR § 820.40, as required by 21 CFR § 820.181. [FDA-483 Item 17]. For example, you did not have or failed to provide the device master record for each of the three referenced devices.
5. Failure to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR § 820.184. [FDA-483 Item 16]. For example, you stated that your firm did not maintain device history records to include acceptance records, the dates of manufacture, the quantity manufactured, the quantity released for distribution, and the primary identification label and labeling for the above-referenced devices.
6. Failure to establish and maintain instructions and procedures, including documentation of servicing, for performing and verifying that the servicing meets the specified requirements, as required by 21 CFR § 820.200 (a) and (d). [FDA-483 Item 18]. For example, your firm failed to establish and maintain written service procedures and service reports for the leased (used) NVGS 9000 and 9000 II devices that were returned to your firm for servicing and redistribution. You called the repeat process of leasing (renting), servicing, and distributing these used devices a "recycling" process.
7. Failure to establish and maintain procedures and records for control and distribution of finished medical devices to ensure that only those devices approved for release are distributed, as required by 21 CFR § 820.160(a) and (b). [FDA-483 Item 11. For example, you did not have or failed to provide distribution records of the above-referenced devices.
8. Failure to establish and maintain procedures and records to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR § 820.30(a) through (j). (FDA-483 Items 2 through 10). For example, you did not have or failed to provide design control procedures and records for your firm's design plan, design input, design output, design review, design verification, design validation, including the design risk analysis, design transfer, design change, and design history file for the E-Strip Disposable lontophoretic Treatment System, a Class III medical device that is intended to transport ions of soluble salts or other drugs into the body for medical purposes.
9. Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all the requirements of 21 CFR § 820.198(a) through (e) are met. [FDA-483 Item 111. You stated that your firm has never received any complaints, but your firm's complaint handling procedure failed to:
a. Designate and document a formally designated unit to handle complaints.
b. Identify and evaluate all possible sources of complaints (e.g. oral and written complaints, customer inquiries, product returns, service reports, etc.)
c. Establish and maintain requirements to ensure all complaints are processed in a uniform and timely manner.
d. Establish and maintain requirements for evaluating complaints and explaining whether an investigation is necessary or why no investigation is conducted.
e. Establish and maintain complaint records to document all the information required in 21 CFR § 820.198(e)(1) through (e)(8).
Medical Device Reporting Regulation
The above-stated inspection also revealed that your devices are misbranded within the meaning of Section 502(t)(2) of the Act (21 U.S.C. § 352(t)(2)) because your firm failed to establish and maintain a written MDR procedure, as required by 21 CFR § 803.17. [FDA 483 Item 12].
Device Listing of Domestic Establishments
Your devices are further misbranded within the meaning of Section 502(o) of the Act (21 U.S.C. § 352(o)) because your firm failed to submit a list for the E-Strip Disposable lontophoretic Treatment System as required by Section 510(j) of the Act (21 U.S.C. § 360j) and the Device Listing Regulation, 21 CFR § 807.20(a)(1).
Establishment Registration and Device Listing of Foreign Establishments
The above-stated inspection also revealed that [redacted] has not registered its establishment as an exporter of the E-Strip Disposable Iontophoretic Treatment System and the HVGS 9000 II and listed these devices with FDA, as required by 21 CFR § 807.40(a). The failure of your foreign establishment to register and list may cause your imported devices to be misbranded within the meaning of Section 502(o) of the Act (21 U.S.C. § 352(o)). If you believe that [redacted] has registered its establishment and listed its devices with the FDA, please provide your documentation for FDA's review.
Responding to This Letter
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 the regulations. The specific violations noted in this letter and in the Form FDA 483 may be symptomatic of other serious underlying problems in your firm's manufacturing and quality assurance systems.
Because of the serious nature of your violations and/or your failure to maintain, document, or provide the names and addresses of your actual foreign contract manufacturers, you must take immediate action to correct all violations of the Act and FDA regulations. Failure to promptly correct your firm's violations may result in regulatory action being initiated by the FDA 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 about devices so that they may take this information into account when considering the award of contracts. Additionally, no applications for premarket approval to which the QS regulation deficiencies are reasonably related will be 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.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken or will take to identify and correct the noted violations, including (1) the timeframes within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to ensure that similar violations will not recur.
Your response should be sent to Thao Ta, Compliance Officer, DAL-DO, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, TX 75240. If you have any questions about the contents of this letter, please contact Mr. Ta at 214-253-5217.
Michael A. Chappell
Dallas District Director