Inspections, Compliance, Enforcement, and Criminal Investigations
Kwonnie Electrical Products Limited 3/3/08
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Center for Devices and|
9200 Corporale Blvd
Rockville, MD 20850
MAR - 3 2008
Kwok Chan Yiu
Kwonnie Electrical Products Limited
3rd Industrial Estate
Dongguan, China (Mainland)
Dear Mr. Yiu:
During an inspection of your firm located in Dongguan, China, on September 3, 2007 through September 6, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures paraffin baths. 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.
This inspection revealed that this device is 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 their 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 a response from William, email@example.com, via a facsimile dated October, 23, 2007, concerning our investigator's observation #8, Medical Device Reporting, noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below, in relation to the noted violation.
The violations include, but are not limited to, the following:
1. Failure to ensure that when results of a process cannot be fully verified by subsequent inspection and test, to validate with a high degree of assurance and approved according to established procedures, as required by 21 C.F.R. § 820,75(a).
• Your firm did not conduct a process validation for the automated plastic injection molding process that produces several paraffin bath plastic components such as the bottom housing, middle housing, and cover.
• Your firm did not establish criteria for determining when revalidation of the injection molding process is necessary.
• Your firm is operating at the outside of the limit 75 degrees Celsius specification for SAN resin drying and your firm did not have documentation of the accuracy of the drying thermometer.
2. Failure to review and evaluate the process and perform revalidation where appropriate when changes occur, as required by 21 C.F.R. 820.75(c).
For example, your firm did not adequately evaluate the added foam pads to clean the air going into their injection molders. Your firm did not assess the need to perform revalidation for this change.
3. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use, as required by 21 C.F.R. § 820.70(g).
• The resin air intake ports were modified by adding a piece of foam to filter the air, but there was no documentation of verifying that the addition would not be detrimental to the process.
• There are no written procedures stating when to clean and maintain the foam pieces.
• Three of fourteen Battenfeld injection molding machines did not have foam on the intake ports. Half the machines had partial foam covering the air intake ports.
4. Failure to maintain device master records (DMR's), as required by 21 C.F.R. § 820.181.
For example, your firm's most recent device history record documentation for the paraffin bath injection molded components found that Kwonnie did not maintain a device master record detailing the required processing specifications for injection molding.
5. Failure to adequately maintain procedures for acceptance activities, as required by 21 C.F.R. § 820.80(a).
For example, your firm does not have a written procedure to control the use of a stamp, which acts as a signature that releases raw material for processing. Therefore, this stamp may be used without any authorization.
6. Failure to establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met as, required by 21 C.F.R. § 820.80(c).
• Your firm's process monitoring is inadequate in that a production of injection molded cord clamps (paraffin bath components molded from PC resin) was released for further assembly without the required supervisor's approval of the "Injection Parameter Record."
• The QA department reviewed a production lot and released the lot for production without having supervisory approval of the "injection parameter record."
7. Failure to establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed, as required by 21 C.F.R. § 820.150.
For example, the critical component storage control for the paraffin baths lacked: written specifications for heating wire storage; documentation to support the adequacy of storage conditions of 0%-95% humidity for heating thermostats, cooling thermostats, and thermal fuses; and documentation to support the PP and PC resin storage requirements. Components were stored in a warehouse, open to the outside air, with no humidity or temperature control.
8. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 C.F.R. 820.30(h).
•The paraffin bath design controls had no documentation of approval and release of the final design for paraffin bath models 967, 968, and 990.
•There are no written quality system documents, agreements, or quality transfer mechanisms between Kwonnie and (b)(4) originally was responsible for the earlier design models of paraffin baths, but there are no written procedures or agreements stating which firm is responsible for the design and which firm has the authority to make design changes.
•There is no written agreement between Kwonnie and (b)(4) detailing which firm is responsible for design verification, design validation, design transfer or design changes.
• Your firm's design control procedures did not have specific criteria for determining when verification is sufficient in lieu of validation.
9. Failure to establish and maintain procedures for validating the device design to ensure that the devices conform to intended uses, as required by 21 C. F.R. § 820.30(g).
For example, your firm's design validation is inadequate in that there is no documentation to indicate paraffin bath design validation for the intended use of "relief of pain caused by arthritis, bursitis, and chronic joint inflammation" for models 967, 968, and 990.
10. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 C.F.R. § 820.90(a).
For example, your firm has no documentation for the disposition of three white light component failures (non conformities).
11. Failure to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 C.F.R. § 820.50(b).
• There are no written agreements and procedures between (b)(4), and your firm prescribing the specifications and sampling for the finished device testing and acceptance testing and no procedure prescribing the necessary acceptance records required by the regulation for these activities. Further there is no agreement and procedure between the three parties to ensure the review and approval of all activities required in the Device Master Record and to ensure the Device History Record demonstrates the device was manufactured in accordance with the Device Master Record.
• There are no written agreements and procedures between (b)(4), and your firm, indicating who has authority for lot release and distribution and how the release is to be implemented and controlled. The (b)(4) QA Manager stated that the current agreement between (b)(4) and your firm has not been formalized.
• There are no written agreements and procedures between (b)(4), and your firm established to document, exchange, and coordinate the handling, investigating and analyzing of nonconforming data, complaints and corrective and preventive actions.
Our inspection also revealed that your paraffin baths 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 by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1. Failure to comply with 21 C.F.R. § 803.17(a), requirements for developing, maintaining, and implementing written MDR procedures for a manufacturer. For example, your firm must develop, maintain, and implement written MDR procedures for internal systems that provide for:
• Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements: and
• Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.
2. Failure to comply with 21 C.F.R. § 803.17(b), documentation and recordkeeping requirements, for:
• Information that was evaluated to determine if an event was reportable;
• All medical device reports and information submitted to manufacturers and/or FDA;
• Any information that was evaluated for the purpose of preparing the submission of annual reports: and
• Systems that ensure access to information that facilitates timely follow-up and inspection by us.
We have reviewed your emailed response and have concluded that it is inadequate because the revised procedure does not address sections of 21 C.F,R. § 803.17(a) and (b), as stated above.
Given the serious nature of the violations of the Act, all models of paraffin baths manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381 (a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.
Also, U.S. 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, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations. or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to: Valerie A. Flournoy, Branch Chief, General Hospital Devices Branch, HFZ-333, 9200 Corporate Blvd, Rockville. MD 20850. If you have any questions about the content of this letter please contact: Valerie Flournoy at 240-276-0115 or FAX 204-276-0114.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Timonthy A. Ulatowski
Office of Compliance
Center for Devices and