Inspections, Compliance, Enforcement, and Criminal Investigations
Richway NF 1/9/13
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
January 9, 2013
VIA UNITED PARCEL SERVICE
Ms. Kim Soo-Hyun
Chief Executive Officer
58-4 Beon 3-dong, Gangbuk-gu
Seoul, South Korea
During an inspection of your firm located in Seoul, South Korea,on July 30, 2012, through August 2, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Biomat heating pad device. 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.
Our inspection revealed that the Biomat heating pad 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.
We received a response from you dated August 10, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that 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:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, written MDR procedures have not been developed by the firm.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided clarification regarding its role in customer service and complaint handling. Your firm indicated that it does not provide users of the Biomat heating pad with customer service and that customer relations and complaint handling is the responsibility of Richway Inc. in Honolulu. However, your firm conducted an evaluation of reports of user injury communicated by Richway Inc. in accordance with its new complaint procedure. Additionally, the response indicated that a section has been created in this procedure to describe MDR reporting to the FDA, a new coordinated effort with Richway, Inc. Your firm indicated that it provided attachments to demonstrate that these corrections have been made; however, these documents could not be found. It is unclear whether your firm has implemented this corrective action and what measures it will take to ensure that MDR reportable events are reported as required by 21 CFR Part 803.
Also, 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 awarding of contracts.
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, as well as 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 actions (including any systemic corrective actions) 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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
- Failure 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, complaint files are not maintained. Specifically, your firm does not receive and document complaints from Richway International, Inc., for the Biomat device.
We reviewed your firm’s response and conclude that it is not adequate. The response indicated that as the contract manufacturer for Richway Inc., your firm does not receive complaints from device users or caregivers that use the Biomat product and that all customer complaints are managed by Richway, Inc.’s Honolulu Office. The response stated that a procedure was developed to define the actions that must be taken by your firm when a client either complains or informs the company of a quality issue with the product manufactured by Richway NF. Additionally, your firm’s response indicated that the new procedure and the training records were provided, however, these attachments could not be found. It is unclear whether your firm has implemented these corrective actions or considered a systemic corrective action.
- Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR), as required by 21 CFR 820.184. For example, the DMR for the Amethyst Bio-Mat devices released on June 15, 2012, July 2, 2012, and July 12, 2012, do not include the following:
a. Evidence demonstrating that a final inspection was performed on the devices prior to release,
b. The location of the primary identification label and labeling used for each product, and
c. Evidence demonstrating that all of the device components and accessories were included in the packaged device.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that a corrective and preventive action (CAPA) was initiated to determine the root cause of the events which led to the incomplete information in the DHR. Your firm estimated that between (b)(4) to (b)(4) would be needed to adequately conduct an investigation, develop preventive measures, and develop a plan to assess the effectiveness of this CAPA. Additionally, your firm indicated that it developed a DHR review checklist that will be used prior to the release of product. This checklist would then be reviewed by supervisory personnel to ensure its completeness. Only after the checklist is completed would product be released to the customer (Richway, Inc.). However, your firm did not provide any technical information about the CAPA it initiated or details regarding the implementation of the DHR checklist and corrective action. Also, no evidence that your firm considered a system corrective action was provided.
- Failure to establish and maintain adequate procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, incoming acceptance records do not contain evidence demonstrating that your firm’s incoming Biomat sampling plan was followed for incoming materials. Specifically:
a. On May 10, 2012, (b)(4) were received. According to your firm’s Biomat sampling plan, (b)(4) pieces were to be sampled and inspected. However, only (b)(4) samples were inspected.
b. On November 13, 2011, (b)(4) pieces of (b)(4) was received and (b)(4) pieces were received on October 26, 2011. However, there was no record of an incoming inspection being conducted.
We reviewed your firm’s response and conclude that it is not adequate. The response stated that a CAPA was opened to determine the root cause of the events that led to the inconsistent sampling. The response also indicated that the inspection forms have been revised to require supervisory review of incoming materials after the inspection and before the release of incoming material as approved. However, your firm did not provide any technical information about the CAPA it initiated for this observation. No details regarding the implementation of the correction and the corrective action for your firm’s revised inspection forms were provided. Your firm did not provide evidence demonstrating that employees were trained on the updated inspection form. Also, your firm provided no evidence that it considered conducting a systemic corrective action.
Your firm’s response should be sent to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance, Field Operations Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 2099
Refer to the Unique Identification Number 387659 when replying. If you have any questions about the contents of this letter, please contact: Matthew Krueger at 301-796-5585 or via fax at 301-847-8139
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 Radiological Health
Cc: Mr. Calvin Kim
Richway International, Inc.
1314 South King Street, Suite 520
Honolulu, Hawaii 96814