Bionet Co., Ltd. 7/27/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampshire Avenue Silver Spring, MD 20993

JUL 27 2011

WARNING LETTER

VIA UNITED PARCEL SERVICE

Dong Joo Kang
CEO and President
Bionet Co., Ltd.
#1101 E&C Venture Dream Tower III
197-33, Guro-Dong
Guro-Gu, Seoul, 152-050
Republic of (South) Korea

Dear Mr. Joo Kang:

During an inspection of your firm located in Seoul, Republic of (South) Korea on April 18, 2011, through April 21, 2011, an investigator from the United Sates Food and Drug Administration (FDA) determined that your firm manufactures patient monitoring systems, fetal monitoring systems, and ECG analysis systems. 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 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response from Kim DongPill, Chief Operating Officer and Vice President, dated May 4, 2011, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to you. 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 establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). 

Specifically, your firm's CAPA procedure, BQP-QM-O9, does not define how CAPA will be implemented and documented. This procedure does
not define the following:

a. How quality incidents will be investigated;
b. How actions necessary to correct and prevent quality problems will be identified and implemented;
c. How corrective and preventive actions will be verified or validated for effectiveness and that the action taken does not have an adverse impact on product;
d. How necessary changes to documentation will be identified and taken;
e. How results will be disseminated to responsible personnel and Management Review; and
f. How all CAPA activities will be documented.

For example, your firm stated that it does not follow the procedure, that there is no CAPA form, that it does not have a formal method for taking and documenting CAPAs, and that all corrective and preventive actions are taken outside of any CAPA system.  Additionally, your firm currently takes action regarding quality problems by using (b)(4) quality system database. The following three quality events from the database were reviewed and none were performed or documented in accordance with any CAPA procedure:

• (b)(4)
• (b)(4)
• (b)(4)

The adequacy of your firm's response dated 05/04/2011 cannot be determined at this time. Your firm provided a revised copy of its CAPA procedure, BQP-QM-DS, and newly created documentation for the three quality events reviewed by the investigator. However, during the discussion of the observation with your firm's management, your firm stated that it would perform a retrospective review of previous quality events. This retrospective review has not been provided to FDA for review.

2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your firm's complaint procedure does not define how the evaluation of complaints for MDR reportable events will be documented. Additionally, your firm's complaint form does not contain a field for an evaluation for MDR reportable events. For example, four complaints were reviewed and none contained documentation that an evaluation for MDR reportable events was conducted.

Your firm's response dated 05/04/2011 is not adequate. Your firm provided a revised copy of their Complaint Handling procedure and the Service Report Form from (b)(4). However, your firm has not provided evidence of implementation of the new Complaint Handling procedure and Service Report Form and have not performed a retrospective review of complaints to ensure an evaluation for MDR reportability was performed. Furthermore, your firm has not documented evidence of implementation of corrective actions including the consideration of systemic corrective actions.

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 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 actions 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 these 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.

Your firm's response should be sent to: Zachary Showman, Field Operations Branch, Division of Risk Management Operations, Office of Compliance, W066 RM2613, 10903 New Hampshire Avenue, Silver Spring, MD, 20993. Please refer to CMS #197392 when replying. If you have any questions about the content of this letter please contact: Joshua Simms at (301) 796-5599 or (301) 847-8128.

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 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 closeout 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 to bring the products into compliance.

Sincerely yours,

/s/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
 

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