Inspections, Compliance, Enforcement, and Criminal Investigations

Nanentek Factory 3/2/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

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

 

WARNING LETTER
MAR 2, 2015 
 
VIA UNITED PARCEL SERVICE
 
Mr. Jinhyung Park
President and CEO
Nanentek Factory
12F, 5, Digital-ro 26 Gil, Guro-gu
Seoul, Korea
 
 DearMr. Park:
 
During an inspection of your firm located in Korea, Republic of Southon September 01, 2014 through September 05, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures FREND Instrument and Diagnostic Kits and Cell Counting Devices.  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. These violations include, but are not limited to, the following:
 
1.    Failure to establish and maintain procedures for implementing corrective and preventive action as required by 21 CFR 820.100(a).
 
For example, your firm failed to document corrective actions and investigational activities. Specifically, corrective action information was not documented for CAPA C-14-06-016, which was opened to address a motor drive malfunction for the ADAM-rWBC. CAPA C-14-06-016 was opened in response to complaint CCR-AD060414-001. 
 
2.    Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). 
 
For example, there was no documentation of the nonconformance nor an evaluation to determine whether an investigation was needed for the expired C-Chip Hemocytometer (expired 6/8/2014) that was discovered and documented on 8/22/2014 by the firm.
 
3.    Failure to establish and establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling and verifying the acceptability of process capability and product characteristics where appropriate, as required by 21 CRFR 820.250(a).
 
For example, the number of products manufactured to validate a production process change was not based on valid statistics. During the review of the validation for a process change to FREND PSA production the investigator request to review your firm’s procedure for identifying valid statistical tools to determine appropriate sample sizes for validation purposes.  
 
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(s) 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 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #446343 when replying. If you have any questions about the contents of this letter, please contact: James Woods at 301-796-6225.
 
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. 
 
 
Sincerely yours,
/S/                                                           
Alberto Gutierrez
Director
Office of In Vitro Diagnostics and
    Radiological Health
Center for Devices and
    Radiological Health

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