Inspections, Compliance, Enforcement, and Criminal Investigations
Ultrasonic Services, Inc 17-Jul-06
Department of Health and Human Services
Public Health Service
July 17, 2006
RETURN RECEIPT REQUESTED
Mr. James Feine, President
Ultrasonic Services, Inc.
7126 Mullins Drive
Houston, Texas 77081-5908
Dear Mr. Feine:
During an inspection of your establishment located in Houston, Texas on March 13 through 16, 21, and 24, 2006, our Investigator determined that your firm manufactures the
USI 25 MPLC and USI 25 M Manual Tune Ultrasonic Dental Scaler and their dental accessories, e.g. the insert, hand piece, and foot switch. The Dental Scalers and their dental accessories are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), in that it is intended for use in the cure, treatment, prevention, or diagnosis of a disease or medical condition, or because it is intended to affect the structure or any function of the body.
The above-stated inspection revealed that these devices are adulterated under 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 conformance with the Current Good Manufacturing Practice (CGMP) requirernents for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR § 820.30(i). [FDA 483 Item 6]. For example:
a. Your firm failed to establish design change procedures to initiate, review, approve, document, and control design changes.
b. Although your firm maintained an engineering drawing for the current USI 20 Series Inserts, your firm failed to document a description of the design change from the USI 10 Series Inserts to the USI 20 Series Inserts (e.g. marketing demands, customer inputs, product issues, design deficiencies, etc.).
c. Your firm failed to document the results of design verification (e .g. functional testing) or design validation (e .g. user testing or customer evaluation) and a formal risk analysis assessment for the design change.
2. Failure to establish and implement procedures for implementing corrective and preventive actions and documenting the results of these actions, as required by 21 CFR § 820.100(a), and (b) and 21 C FR § 820.200(b). [FDA 483 Item 9]. For example, your firm has not analyzed service reports (e.g. electronic invoice database) to identify existing and potential causes of nonconforming product, or other quality problems and documented the results of your analysis.
3. Failure to establish and maintain procedures for changes to a specification, method, process, or a procedure, as required 21 CFR § 820.70(b), and to ensure that document changes are approved in accordance with 21 CFR § 820.40. For example, at the time of the inspection, .your firm was using a draft assembly procedure "Build Operations: Headpiece for Manual Units" that contained handwritten changes. It is unclear as to why and when the changes were made. Your firm has not verified the handwritten changes, approved and finalized this draft procedure for officiaf use, and assigned a document version number and an effective date.
4. Failure to adequately validate manufacturing processes with a high degree of assurance, approve, and document the results of the validation activities to ensure that
product specifications can be consistently met, as re uired by 21 CFR § 820.75(a). [FDA 483 Item 5]. Your firm purchased the [redacted] Welder to weld the insert tips and stack materials. The Instruction Manual of this weldin machine provides the principles of operations and recommendations on using the [redacted] Welder. Your firm has not established and validated a welding procedure that defines, tests, optimizes and documents specific welding material and parameters for your insert tips and [redacted] stacks (e.g. a specific metal material to be welded, the method of welding, the use o a specific welding tip ; welding temperature, time, and acceptance criteria for the inspection and physical testing of the welded parts).
5. Failure to establish and maintain adequate process control procedures that include documented instructions, standard operating procedures (SOP), and methods that define and control the manner of production, as required by 21 CFR §820.70(a)(1). [FDA 483 Item 4]. For example :
a. Your firm failed to establish written procedures for the assembly of the foot switches and inserts and for the [redacted] brazing [redacted] welding of the insert tips and [redacted] strips/stacks. The foot switch is to activate power and water flow as well as providing power control. The stack materials are to provide mechanical vibrations of the insert tip.
b. Your current assembly procedure (Build Operations) for the Ultrasonic USI Dental Scater Unit (generator) does not state or reference the specific component part number and the quantity of components to be assembled into the generator and adequate testing instructions . For example, Operation 8 of the procedure states to install a transistor but does not specify the type of the transistor or its part number. Operation 7 states to install circuit boards but did not state the type and how many circuit boards are to be installed. Operation 21 states to test the generator after assembly but does not explain or reference the specific testing instructions and acceptance criteria.
6. 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 8] . For example, your firm does not have a complaint handling procedure that:
a. Documents a formally designated unit to handle complaints.
b. Identifies and evaluates al! possible sources of complaints (e.g. oral and written complaints, customer inquiries, product returns, service reports, etc.)
c. Establishes and maintains requirements to ensure all complaints are processed in a uniform and timely manner.
d . Establishes and maintains requirements for evaluating complaints and explaining whether an investigation is necessary or why no investigation is conducted.
e. Establishes and maintains complaint records to document all the information required in 21 CFR § 820.198(e)(1) through (e)(8).
7. Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required 21 CFR § 820.80(d), and includes acceptance records, as required by 21 CFR § 820 .80(e). [FDA 483 Items 2 and 3]. For example, your firm failed to-(a) establish written procedures for the testing or inspection of your ultrasonic dental scalers (generators), inserts, headpieces, and foot switches; and (b) keep records of the test or inspection results of these products.
8. 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 1]. For example, your firm failed to establish a device master record for your ultrasonic USI dental scalers (generators), insert tips, hand-pieces, and foot switches.
9. Failure to establish and maintain adequate service reports to include test and inspection data, as required by 21 CFR § 820.200(d). [FDA 483 Item 7]. Your firm has not maintained adequate test and inspection data in your electronic invoice database on the servicing or repair of your customers' ultrasonic dental scalers (generators), inserts, handpieces, and foot switches. For example, although your invoice database documents certain components that were replaced to correct a malfunction, it does not document or reference specific details of whether and how these products were inspected or tested after their servicing or repair.
The above stated inspection also revealed that your devices are adulterated under section 501(f)(1)(B), 21 U.S.C. 351(f)(1)(B), in that it is a class III device under section 513(f), 21 U.S.C. 360c(f), and does not have an approved application for premarket approval in effect pursuant to section 515(a), 21 U.S.C. 360e(a), or an approved application for an investigational device exemption under section 520(g), 21 U.S.C. 360j(g). For a product requiring premarket approval before marketing, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. 21 CFR 807.81(b).
These devices are also misbranded under section 502(o), 21 U.S.C. 352(o), in that the device was manufactured, prepared, propagated, compounded, or processed in an
establishment not duly registered under section 510, 21 U.S.C. 360, was not included in a list required by section 510 (j), 21 U.S.C. 360(j), and a notice or other information
respecting the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k).
Additionally, your devices are misbranded under section 502(t)(2), 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish any material or information required by or under section 519, 21 U.S.C. 360i, respecting the device and 21 CFR Part 803(Medical Device Reporting regulation). The following violations were documented:
21 CFR 803.17 A manufacturer must develop, maintain, and implement written MDR procedures. For example, your firm failed to develop written MDR procedures. 21 CFR 803.18(a)(b)(1)(i)(ii) A manufacturer must maintain copies of all MDR forms, as required by this part, and other information related to the event that you submitted to us and other entities. For example, your firm failed to address the documentation and recordkeeping requirements for handling and processing information on MDR events and maintaining MDR files.
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 FDA 483 issued at the close of the inspection may be symptomatic. of serious underlying problems in your firm's manufacturing and quality assurance 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 on your quality system.
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 regulation 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 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 money penalties.
On March 23, 2006, you provided a letter to the investigator stating that your firm will come into full compliance with all FDA regulations which would include submitting a 510(k) for your ultrasonic dental scalers and accessories.
Please notify this office in writing within fifteen (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 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 within which the corrections will be completed.
Your response should be sent to Thao Ta, Compliance Officer, Dallas District, 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