Hiossen Inc. 10/5/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||PHILADELPHIA DISTRICT|
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Via United Parcel Service
October 5, 2012
Mr. IkJin Kim
Director, Production Headquarters
85 Ben Fairless Drive
Fairless Hills, PA 19030-5012
Dear Mr. Kim:
During an inspection of your facility located in Fairless Hills, PA, from April 30, 2012 to May 16, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures dental implant fixture sets for human use. Under Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 321(h)], these products are defined as 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 any function of the body.
The 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, processing, 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. At the conclusion of the inspection, Inspectional Observations, Form FDA 483 (FDA 483), was issued to and discussed with you, and identified deviations, including but not limited to:
1. Management with executive responsibility has failed to ensure that the quality policy is understood, implemented and maintained at all levels of the organization [21 CFR § 820.20 (a)].
For example, from October 28, 2008 to the present at least (b)(4) returned dental implants have not been adequately evaluated in a manner consistent with your quality manual and policy; there is no assurance that a critical design feature (b)(4) has been applied to each fixture; there is no assurance that in-process non-conforming product is evaluated; failure to follow your procedures regarding design activities and design history file documentation; failure to document training of sales representatives from 2006 to 2012 on handling customer feedback; and failure to define returned product handling in your internal audit checklist. These failures of executive management hinders your ability to determine if product returns are complaints, failures or non-conforming product, which may question process validation or the need for further investigation or MDR reporting.
2. Failure to establish adequate procedures for receiving, reviewing and evaluating complaints by a formally designated unit [21 CFR § 820.198 (a)].
For example, you have failed to follow your own procedure for receiving, reviewing and evaluating complaints; therefore preventing the receipt and review of information from customers which may indicate the occurrence of adverse events, product non-conformances, or user error, which would demonstrate the need for further investigation.
3. Failure to adequately document process validation activities and results [21 CFR § 820.75 (a)].
For example, you have removed a component (b)(4) of the (b)(4) Machine without justification that removal of this component would have no effect on machine performance or product quality; and there is no documentation to justify (b)(4) specification, or changes made to this specification.
4. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met; results of your design validation and verification, including identification of the design, are not contained in the design history file [21 CFR § 820.30 (g) and (f)].
For example, there was no documentation of any design validation activities for the ET-III SA Fixtures; the device history file contained validation data for a similar device manufactured in Korea; however there was no documentation that the manufacturing processes are similar. In addition, some of the data was in Korean and the investigators were unable to determine if the data was relevant. Also, design verification results were not adequately documented in the design history file.
We acknowledge receipt of your letter dated June 5, 2012 in response to the FDA 483, and follow-up letters dated August 3, 2012 and September 7, 2012. Your written responses and verbal commitments made during the inspection provide a series of planned or completed corrective actions that you believe will bring the company into compliance with the QS Regulation. Your proposed corrective actions appear to be moving your company towards compliance; however corrective actions lack supporting documentation. Your corrective actions will be further evaluated during the next inspection at your facility.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, 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.
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 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 with all requirements of federal law and FDA regulations.
Your response should be sent to: Kirk D. Sooter, District Director, Room 901 U.S. Customhouse, Philadelphia, Pennsylvania, 19106-2973. If you have any questions about the content of this letter please contact: Richard C. Cherry, Compliance Officer, at (215) 717-3075 (phone)or Richard.Cherry@FDA.HHS.GOV
Kirk D. Sooter