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U.S. Department of Health and Human Services

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Enforcement Actions

GRI Medical & Electronic Technology Co., Ltd. 5/1/13

  

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 20993-0002 

 

May 1, 2013
 WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
 
Martin D. Paugh
Executive Vice President
GRI Medical & Electronic Technology Co., Ltd
1805 Honggao Road
Jiaxing, Zhejiang,
314031, China
 
Dear Mr. Paugh:
 
During an inspection of your firm located in Jiaxing, Zhejiang, on December 17, 2012, through December 20, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures sterile and non-sterile products: surgical gowns, surgical drapes, ophthalmic patient drapes, compressible limb sleeves, I.V. containers, light handle covers, blood lancets, specimen containers, mattress covers, emesis basins/bowls, basin strainers, stand and equipment covers, clamps, stockinettes, pelvic braces, knee/ankle braces, magnetic instrument pads, collection bottles, medical disposal beddings, absorbent tipped applicators, graduated liquid containers, alcohol pads and surgical apparel accessories. 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.
 
We received a response from you dated January 22, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which 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:
 
1.    Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example: your firm’s Corrective and Preventive Action (CAPA) Procedure, Document # SOP-JX-27, Revision 04, is incomplete in that your firm has yet to establish requirements/criteria/limits that would trigger a CAPA based on factors such as data analysis of  complaints, process rejects, supplier performance. A review of your firm’s 2012 CAPAs revealed that these CAPAS were not based on data analysis.
  
We reviewed your firm’s response and conclude that it is not adequate. The response contains a copy of the updated Procedure Document, # SOP-JX-27, Revision 05, effective December 29, 2012, to establish requirements/criteria/limits that would trigger a CAPA. The response contained a copy of an updated Procedure Document, # SOP-JX-025, Revision 02, for a procedure to address issues when a (b)(4) is determined from collected data analysis. The response included a record of training for appropriate employees on both # SOP-JX-27 and SOP-JX-025 updates; however, the response does not provide evidence of a systemic corrective action plan. Your firm did not perform a retrospective data analysis to confirm that complaints were appropriately investigated.
 
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, your firm’s Non-Conforming Product Control Procedure, Document #SOP-JX-24, Revision 04, states that the purpose of the procedure is to establish controls for identification, documentation, evaluation, segregation, and disposition of suspected nonconforming products. However, the following nonconforming products were observed in various red bins without identification documentation as required by your firm’s Non-Conforming Product Control Procedure:
 
  • (b)(4)
  • (b)(4)
  • (b)(4)
  • (b)(4)
  • (b)(4)
  • (b)(4)
 
We reviewed your firm’s response and conclude that it is not adequate. The response indicated that # SOP-JX-24, Non-Conforming Product Control Procedure, was updated to clarify that in-process scrap material is identified and documented on Form GRI- JX-F116. Your firm’s response contained a change to JX-045, the Working Instruction of Lot Product Traceability, to define that scrap product shall be documented at (b)(4). A section to record rejects from raw process was added to GRI-JX-F116. The response referenced that the complete training record would be completed in (b)(4) and a procedure audit would occur in the (b)(4). Additionally, evidence of a systemic corrective action plan that addresses the conformance or nonconformance of all products with acceptance criteria was not provided.
 
3.    Failure to develop, conduct control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example:
 
a.    Your firm's In-Process Inspection Protocol, KC Surgical Gown, Document, #QA-JX-02, Surgical Gown, Revision 06, requires (b)(4) inspection for (b)(4) surgical gowns to be conducted (b)(4). However, during a walk-thru of the facility on December 17, 2012, it was noted that (b)(4) inspections had been performed for the manufacturing of the KC Surgical Gown - Large (Lot #(b)(4)) from (b)(4) (on the (b)(4)).
 
b.    Your firm’s Equipment Parameter Specification for the (b)(4) Sealer, Equipment # (b)(4) is the following:
 
Material Configuration-(b)(4)
  • Temperature (F) - (b)(4)
  • Air Pressure (Psi) – (b)(4)
  • Speed (inch/minute) – (b)(4)
 
However, during a walk through of the facility on December 17, 2012, it was noted that the sealer was set and ran at the following parameters in the packaging of sterile KC Impervious Extra-Long Femoral Angiography Drape, Lot #(b)(4), at (b)(4):
 
  • Setting-(b)(4)
  • Speed (inch/minute) (b)(4)
  • Readout-(b)(4)
  • Speed (inch/minute) (b)(4)
 
We reviewed your firm’s response and conclude that it is not adequate. The response included a corrective action to re-train inspectors on SOP-JX-02, Quality Record Control Procedure, to ensure that inspectors document inspection results in a timely manner. The response also noted a plan for a follow-up audit during the (b)(4). Your firm provided a corrective action to update SOP-JX-22, Product Monitoring and Measurement Procedure, and a record indicating retraining of staff on following parameter specifications and verifying parameters before beginning production. Your firm’s response included rework sheets for parameter specification for the (b)(4) Sealer and a plan for a follow-up audit to be scheduled during the (b)(4). However, evidence of a systemic corrective action was not provided. Your firm did not provide information stating that it reviewed the production processes for all devices to ensure that they comply with the requirements of 21 CFR 820.70(a). 
 
4.    Failure to establish and maintain 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 In-Process Inspection Protocol, KC Surgical Gown Document #QA-JX-02, Surgical Gown, Revision 06, requires (b)(4) inspection for (b)(4) surgical gowns to be conducted every (b)(4), based on the (b)(4). Your firm failed to follow its procedure in that only (b)(4). Examples of this can be found in the inspection data sheets DHR # (b)(4), DHR # (b)(4), and DHR # (b)(4).
 
We reviewed your firm’s response and conclude that it is not adequate. The response described how the inspectors did not correctly calculate their sampling plan. Your response contained a training plan on the sampling procedure. The response indicated a plan for (b)(4) to ensure that samples are conducted based on procedure. However, evidence of a systemic corrective action plan to ensure that sampling methods are adequate for their intended use was not provided.
 
5.    Failure to control labeling and packaging operations to prevent labeling mix‑ups, as required by 21 CFR 820.120(d). Specifically, your firm’s Device History Record (DHR) Procedure #SOP JX-31, Revision 03, requires accurate labels that identify the product to be included or referenced in the DHR. During the inspection, (b)(4) DHRs from (b)(4), pertaining to the KC Surgical Gowns, were selected for review; (b)(4) of the DHRs included or referenced the location of the primary identification and labeling used for each production unit.
 
We reviewed your firm’s response and conclude that it is not adequate. The response contained a corrective action plan to train the appropriate employees on proper primary labels and ensure that they are placed in the DHR. Revision to SOP- JX-31 was made, to reflect that Quality Engineer (QE) verify that the proper label is in DHR. Your response referenced the following: SOP-JX-31 training will be completed by January 15, 2013, the QE (b)(4) verification record will be completed by (b)(4), and an audit will be completed for (b)(4). The response does not demonstrate evidence of a systemic corrective plan to control labeling activities for all products.
 
6.    Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, your firm’s (b)(4) Quality System Audit procedure, #SOP-JX-21, Revision 03, requires an (b)(4) quality system audit to be conducted at (b)(4). Your firm failed to conduct the following audits scheduled for (b)(4):
 
Area or Process to Audit                                           Schedule Date
  • (b)(4)                                                                         (b)(4)
  • (b)(4)                                                                         (b)(4)
  • (b)(4)                                                                         (b)(4)
  • (b)(4)                                                                         (b)(4)
  • (b)(4)                                                                         (b)(4)
  • (b)(4)                                                                         (b)(4)
  • (b)(4)                                                                         (b)(4)
  • (b)(4)                                                                         (b)(4)
  • (b)(4)                                                                         (b)(4)
  • (b)(4)                                                                         (b)(4)
  • (b)(4)                                                                         (b)(4)
  • (b)(4)                                                                         (b)(4)
 
We reviewed your firm’s response and conclude that it is not adequate. The response described an unusually large volume of customer audits in (b)(4) that detracted from maintenance of the auditing program to the predetermined schedule. The corrective action to improve (b)(4) auditing for (b)(4) was to assure that all elements were covered, including management review of results. Your response contained a copy of the training record for (b)(4) auditors, the (b)(4) audit certificate, and a copy of the (b)(4) Management Review Agenda. However, evidence of a systemic corrective action was not provided, to assure that the quality system is in compliance with all established quality system requirements.
 
7.    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 and the requirements of 21 CFR 820, as required by 21 CFR 820.184. For example, DHR procedure, Document No. SOP-JX-31, Revision 04, requires that the validated equipment parameter setting record be included or referenced in the DHR. During a walk through of the facility on December 19, 2012, it was noted that the DHRs (b)(4), (b)(4), (b)(4), and (b)(4) failed to include the Operational Record for the (b)(4) Sealer, showing temperature, speed, and pressure-sealing parameters for packaged sterile products.
 
We reviewed your firm’s response and conclude that it is not adequate. The response included an update to SOP-JX-31, for a DHR to add the requirement for the parameters to be recorded in the parameter data sheet for each product and/or lot number run. Your firm’s response included a plan to train production supervisors and inspectors on the change to SOP-JX-31, Device History Record, and a preventive action of a follow-up audit to be scheduled for the (b)(4). However, evidence of a systemic corrective action was not provided. Your firm did not provide information stating that it reviewed all of the DHRs for all devices manufactured by the firm to ensure that they are maintained in accordance with 21 CFR 820.184.
 
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 #394146 when replying. If you have any questions about the contents of this letter, please contact: Carl Fischerat 301- 796-5489.
 
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