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U.S. Department of Health and Human Services

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Enforcement Actions

EMG Manufacturing Co., Ltd. 9/14/12

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

SEP 14, 2012

WARNING LETTER

 

VIA UNITED PARCEL SERVICE
 

Roger Huang
Chief Executive Officer
EMG Manufacturing Co., Ltd.
Shi Da Road, Jinju Village
Dalingshan Town,
Dognguan City 523 820 China 

Dear Mr. Huang: 

During an inspection of your firm located in Dognguan City, China, on June 11, 2012, through June 14, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II Compressor Nebulizers and Class II AC/DC Suction Units.  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.  FDA received a response from you on July 6, 2012, concerning the investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm.  We address the responses 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 validating the device design, as required by 21 CFR 820.30(g).  For example, your firm’s Design Control Procedure (Doc #2-3-01, Ver.1) does not include a requirement (and procedures) for validating the device design.  In addition, the design of the NBX02 Series Compressor Nebulizer-Model #NBA02 A70 was completed in (b)(4), with the (b)(4) shipped to the U.S. in (b)(4); however, no design validation was conducted for this device.  Mr. Ya-Chun Tseng, your firm’s Sales and Marketing Manager, confirmed to the investigator that the design control procedure for the NBX02 Series Compressor Nebulizer-Model #NBA02-A70 did not include a requirement for design validation.

Your firm’s response received on July 6, 2012, is not adequate.  The response references a revised Design Control Procedure; however its specific revisions cannot be determined as the document was not included in the response.  Additionally, your response did not specify how the design control procedure was modified or what was included on the design validation checklist.  Your firm did not provide a description or evidence of implementation of a correction to this observation to include completing design validation for the NBX02 Series Compressor Nebulizer Model #NBA02-A70.  Your firm also did not provide evidence of implementation of a corrective action and consideration of a systemic corrective action to include performing a retrospective review of design validation for other devices to ensure that design validation was completed as required.

2. Failure to establish and maintain adequate acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met, as required by 21 CFR 820.80(c).  For example, your firm’s (b)(4) Assembly Processing Procedure (Doc #NB 1060, Ver. 5) requires each assembled (b)(4) to be tested for (b)(4).  The investigator noted that (b)(4) (Model # (b)(4)) that tested outside of (b)(4) test specification were being allowed to pass.

Your firm’s response received on July 6, 2012, is not adequate.  Your firm had agreed to show the correlation between (b)(4) for the (b)(4) , and to establish specifications accordingly based on this correlation.  The response does not indicate if or how this correlation was determined and what modifications were made to the SOP.  Additionally, your firm did not provide documentation or evidence of implementation of a correction or corrective action.  Your firm did not provide documentation or evidence that it would retrospectively review in-process acceptance activities for the observed (b)(4) to ensure that it is within specification.  Your firm also did not provide documentation or evidence that a systemic corrective action was considered, to include retrospectively reviewing in-process activities for other products to ensure that they were completed as required.

3. Failure to establish and maintain adequate procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c).  For example, your firm’s Environmental, People’s Health, and Product Control Procedure, Document #2-7-02, Version 1, states that the purpose of the procedure is to make sure that the factory environment, people’s health, and product clearing won’t affect the quality of medical device.  In addition, your firm states that the factory environmental hygiene is to avoid pollutions such as dust, waste, and oil.  While your firm maintains this procedure, it allows all windows (with no window screens) to remain open during the entire day, including one of the two docking doors.  This exposes the products and equipment to the outside environment, including pollution.  The investigator noted that the industrial fans meant to cool the manufacturing area actually help circulate dust throughout the room.

Your firm’s response received on July 6, 2012, is not adequate.  Your firm stated that dust-proof equipment would be added in the factory to improve the environmental conditions.  However, your firm did not provide documentation or evidence that the proposed change adequately controls environmental conditions.  Additionally, your firm provided no documentation or evidence that a systemic corrective action was considered, to include reviewing other environmental control procedures to ensure that they were completed as required by Document #2-7-02. 

4. Failure to establish and maintain adequate procedures to ensure that sampling methods are adequate for their intended use and to ensure that, when changes occur, the sampling plans are reviewed, as required by 21 CFR 820.250(b).  For example, your firm’s (b)(4) Procedure (Doc #NB 1030, Ver. 5) only requires (b)(4) to be tested (for (b)(4)) for (b)(4) lot.  The sampling used is not based on a valid statistical rationale.  Specifically, on (b)(4), Production Order # (b)(4), with a lot quantity of (b)(4), had (b)(4) sampled.  Likewise, on (b)(4), Production Order # (b)(4), with a lot quantity of (b)(4), had (b)(4) sampled, and on (b)(4), Production Order # (b)(4), with a lot quantity of (b)(4), had (b)(4) sampled.

Your firm’s response received on July 6, 2012, is not adequate.  Your firm did not provide documentation or evidence that a valid statistical rationale was used for the proposed sampling plan.  Additionally, your firm did not provide documentation or evidence of implementation of a correction or corrective action to include (b)(4) units previously tested using a sampling plan based on a statistical rationale.  Your firm also did not provide documentation or evidence that a systemic corrective action was considered, including reviewing other sampling plans to ensure that they were based on valid statistical rationales.

5. 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).  For example, your firm’s Customer Complaint Procedure (Doc #2-2-02, Ver.1) does not require that complaints be evaluated to determine whether the complaint should be filed as a Medical Device Report (MDR) to the FDA.  All nine complaints reviewed by the investigator lacked MDR evaluation.

Your firm’s response received on July 6, 2012, is not adequate.  Your firm stated that MDR provisions would be added to your firm’s “Customer Complaint Procedure.”  However, your firm did not provide documentation or evidence that the specific MDR provisions were added to the Customer Complaint Procedure.  Additionally, your firm did not provide documentation or evidence of implementation of a correction or corrective action to include completing evaluations of all complaints, including the nine complaints reviewed by the investigator, to determine whether the complaints should be reported to the FDA as MDRs.

6. Failure to establish and maintain adequate procedures to ensure that Device History Records (DHR) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record and the requirements of this part, as required by 21 CFR 820.184.  For example, your firm has yet to establish a DHR procedure.  In addition, (b)(4) DHRs from 2011 and 2012 (pertaining to the compressor nebulizer) were selected for review during the inspection. None of the reviewed DHRs included or referred to the location of the primary identification label and labeling used for each production unit.

Your firm’s response received on July 6, 2012, is not adequate.  Your firm stated that provisions of DHRs would be added to your firm’s “Delivery Control Procedure.”  However, your firm did not provide documentation or evidence that the DHRs’ provisions were added to the Delivery Control Procedure.  Additionally, your firm did not provide documentation or evidence of implementation of a correction to include documenting the location of the primary identification label and labeling used for each production unit for the (b)(4) DHRs reviewed by the investigator, or including the primary identification label and labeling in the DHR, as required.  Your firm did not provide documentation or evidence of implementation of a corrective action and consideration of a systemic corrective action to include review of all DHRs, including the (b)(4) DHRs reviewed by the investigator, to ensure that all labeling locations are documented or referenced as required.

Our inspection also 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 devices 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 violations include, but are not limited to, the following:

Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.  For example, Mr. Ya-Chun Tseng, your firm’s Sales and Marketing Manager, and Mr. Ying-Chun Hsieh, your firm’s QA Management Representative and Auditor, stated that the facility does not have a written MDR procedure.

Your firm’s response received on July 6, 2012, is not adequate. Your firm stated that it would establish a MDR procedure.  However, your firm did not provide documentation or evidence that it has a MDR procedure.  Additionally, your firm did not provide documentation or evidence of implementation of a correction or corrective action.  Your firm did not provide documentation or evidence that it considered a systemic corrective action to include review of all required procedures to ensure that they were established as required.

A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.  

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.  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 action (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.  Please provide a translation of documentation not in English to facilitate our review.  

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 20993.  Refer to CMS case # 341478.  If you have any questions about the contents of this letter, please contact: Tanisha Adams at 301-796-5524. 

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/

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

 

CC:
     Fred Kiwak (US Agent)
     600 Luzerne A venue
     West Pittston, Pennsylvania 18643