- Kawada Sanitary Products Co., Ltd.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
OCT 8, 2014
Kawada Sanitary Products Co., Ltd.
No. 46th Guangfeng Road, Linggang
Torch Development Zone
Zhongshan City, Guangdong
Dear Mr. Wu:
During an inspection of your firm located in Zhongshan City, China, on July 28 through July 31, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures bladder control and menstrual sanitary pads. 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 to affect the structure or function of the body.
This inspection 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, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from your firm, dated August 15, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include but are not limited to the following:
1. Failure to ensure that where the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example:
a. Your firm has not established process validation procedures.
b. Your firm has not validated manufacturing and packaging lines for all products.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that your firm plans to validate manufacturing processes within a six month timeframe. However, your firm’s response did not address when your firm plans to establish process validation procedures and train personnel on the new procedures. Additionally, your firm’s response did not indicate if your firm intends to retrospectively review its processes for similar validation deficiencies.
2. Failure to maintain complaint files and to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
a. Your firm’s Client Complaint Control Procedure, (b)(4), is deficient. Specifically:
i. The procedure does not contain criteria for evaluating complaints for adverse event reportability.
ii. The procedure does not require evaluation of complaints from other countries that pertain to products that are same or similar to those exported to the U.S.A.
b. Your firm has not evaluated the following complaints for MDR reportability:
i. Complaint #20140414-JT-1, which concerned two mini pads in a shipment that had yellow particles on them.
ii. Complaint #20140320-1, which concerned a lot of individually wrapped mini pads that were missing the “easy release” feature at the seal of each packet.
We reviewed your firm’s response and conclude that it is not adequate. Your firm revised its Client Complaint Control Procedure to include the requirement for evaluating complaints from other countries that pertain to products the same as or similar to those exported to the U.S.A. However, your firm’s procedure did not include criteria by which to evaluate complaints for MDR reportability. Your firm’s response did not indicate that your firm will retrospectively review previous complaints for similar deficiencies. Additionally, your firm’s response did not include personnel training records for the revised procedure.
3. Failure to document acceptance activities, as required by 21 CFR 820.80(e).
For example, your firm’s incoming acceptance records for raw materials, such as (b)(4), (b)(4), (b)(4), and (b)(4), do not include identification of measuring or test equipment used for acceptance tests.
We reviewed your firm’s response and conclude that it is not adequate. Your firm revised its Raw Material Inspection Procedure, (b)(4), to include identification of inspection, measuring, and test equipment numbers, and indicated that your firm will conduct training. However, your firm’s response did not indicate that it will retrospectively review acceptance records for similar deficiencies.
4. Failure to maintain device history records (DHRs) and to establish and maintain procedures to ensure that DHRs 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. For example:
a. Your firm has not established a DHR procedure.
b. Your firm’s DHRs do not include or reference the location of a copy of the primary product label.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that your firm has established a Device History Control Procedure, (b)(4), and will conduct training. However, your firm’s response did not indicate that your firm will retrospectively review DHRs for similar deficiencies. Your firm should also submit evidence of personnel training on the new procedure.
5. Failure to establish and maintain procedures to control documents, as required by 21 CFR 820.40.
For example, your firm’s procedure, “Control of Forms” (b)(4), does not contain provisions for controlling revisions to controlled forms.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that your firm revised procedure (b)(4) and will conduct training. However, your firm’s response did not indicate that your firm will retrospectively review its controlled forms and documents for similar deficiencies. Your firm should also submit evidence of personnel training on its revised procedures.
Our inspection revealed that your firm’s 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 CFR Part 803 - Medical Device Reporting (MDR). Significant deviations include, but are not limited to, the following:
6. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm did not have an MDR procedure at the time of the inspection.
We reviewed your firm’s response and conclude that it is not adequate. Your firm developed an MDR procedure, (b)(4), issued August 15, 2014. Review of this procedure found the following deficiencies:
a. (b)(4) does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and definition for the term “reasonably suggests,” found 803.20(c)(1), may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
b. (b)(4) does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
i. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
ii. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
c. (b)(4) does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
i. Instructions for how to obtain and complete the FDA 3500A form.
ii. The circumstances under which your firm must submit initial 30 days, supplemental or follow-up, and 5 day reports and the requirements for such reports.
d. (b)(4) does not describe how your firm will address documentation and record-keeping requirements, including:
i. Documentation of adverse event related information maintained as MDR event files.
ii. Information that was evaluated to determine if an event was reportable.
iii. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
iv. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
U.S. federal agencies may be advised of the issuance of 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.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to the Unique Identification Number (CMS case #437528 when replying. If you have any questions about the contents of this letter, please contact Daniel Walter, Chief, Foreign Enforcement Branch, at 301-796-5587.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and