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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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St. Shine Optical Co., Ltd. 8/26/13

  

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 

 

August 26, 2013
 
 
WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
 
Johnson Chou
Chief Executive Officer and Managing Director
St. Shine Optical Co., Ltd.
4, 5 F/L No. 276-2, Sec. 1
Tatong Road
Hsichin City, Taipei Hsien,
Taiwan
 
Dear Mr. Chou:
 
During an inspection of your firm located in Taipei Hsien, Taiwan, on May 20, 2013 through May 25, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures contact lenses. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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.
 
The inspection revealed that the device is 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 Mr. Brian Lai, Manager, dated June 7, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm on May 23, 2013. 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 ensure that where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example:
 
a.    Your firm’s process validation report for the (b)(4), (b)(4), dated August 11, 2012, tested the (b)(4), used to manufacture the (b)(4). However, the process validation procedure did not include a method to ensure that predetermined specifications are consistently met for the measurements of the final lens power.
 
b.    Your firm’s process validation report for the (b)(4), (b)(4), dated August 11, 2012, includes the method used to ensure that predetermined specifications are consistently met for the manufacture of the (b)(4), which is based on the power of the lenses. However, your firm’s process validation report does not provide objective evidence to support the relationship between the (b)(4).
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it will revise the report form to include the power inspection results according to the revised “Standard Operation Procedure for (b)(4) Machine Validation,” and it will validate the other (b)(4), (b)(4), by June 2013. Also, your firm noted that it will establish a protocol, “Stability Test of (b)(4) Specification Follow-up,” which will measure the (b)(4). However, your firm did not include documentation of the corrections and corrective actions, and your firm did not provide evidence of implementation. Therefore, FDA cannot make an assessment with respect to adequacy.
 
2.    Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm’s CAPA procedure, QA-QP-09, does not include requirements for analyzing all sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Specifically, your firm failed to analyze the lens power testing data that did not meet the predetermined specifications of (b)(4) for lens powers between (b)(4).
 
We reviewed your firm’s response and conclude that is not adequate. Your firm noted that it will establish the stability of lens specification evaluation protocol in order to be able to trace and analyze the records of (b)(4). However, your firm did not provide a plan and evidence of the correction and corrective action, including revision of the CAPA procedure and review of other quality system procedures for adequacy.
 
3.    Failure to establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f). For example, your firm’s design control procedure, “Verification,” RD-QP-01, Section 4.6, does not have a requirement for confirming that the design output meets the design input for range of lens power manufactured. Specifically, your firm conducted verification activities for the Saview 58 UV contact lens in 2008 and the Saview-Aqua 55 UV in 2001 using the lens power of (b)(4). However, the range of the lenses for the Saview 58 UV contact lens is +12.00D to -12.00D and for the Saview-Aqua 55 UV contact lens is +12.00D to -20.00D.
 
We reviewed your firm’s response and conclude that is not adequate. Your firm noted that it will conduct the finished lens test for Saview 58 UV Soft Contact Lens using -13.00 D and +12.00D lenses in order to meet the design output of +12.00D to -12.00D. In addition, your firm noted that it will conduct the finished lens test for the Saview-Aqua 55 UV Contact Lens using -20.00D and +12.00D lenses in order to meet the design output. However, your firm did not include evidence of the corrections and corrective actions, including revision of the design control procedure to include requirements for the design outputs to meet the design input.
 
4.    Failure to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications, as required by 21 CFR 820.70(a). For example, your firm’s procedure, F2-II-06, “Power Inspection,” states that the tolerance limit of the back vertex power measurement should be within (b)(4) for lens powers between (b)(4). However, review of your firm’s Device History Record, (b)(4), shows that the back vertex specification measurements are not always met.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it will establish the stability of lens specification evaluation protocol in order to measure the lens power and evaluate deviation between the insert parameter and the lens power. Additionally, your firm noted that it will execute the protocol, and upon analysis of the deviation, it will adjust the process parameters in order to produce lenses that can meet the (b)(4) specification. Your firm plans to complete this by September 1, 2013. However, your firm did not include documentation of the corrections and corrective actions and the firm did not provide evidence of implementation. Therefore, FDA cannot make an assessment with respect to adequacy.         
 
5.    Failure to establish and maintain procedures to control labeling activities, as required by 21 CFR 820.120. For example, your firm’s label inspection procedure, QA-II-11, details the label inspection procedure for incoming labels and includes the requirement for (b)(4) sampling of (b)(4) labels from the (b)(4) rolls per incoming shipment and states the sampling acceptance and reject levels are (b)(4), respectively. On July 26, 2010, your firm opened a non-conformance, AB10010, with the corrective action to change the (b)(4) sampling of (b)(4) labels from the (b)(4) rolls per incoming shipment and the (b)(4) label from additional rolls received and to change the sampling acceptance and reject levels to be (b)(4), respectively.  However, your firm failed to update the procedure describing the (b)(4) sampling. In addition, your firm failed to update the procedure to include the new requirement for random sampling and acceptance/reject level.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it will revise the “Standard Operating Procedure for Incoming Outer Packages and Labels Inspection” in order to describe the process for selecting samples. In addition, your firm noted that it will train the incoming materials inspectors according to the revised procedure. However, your firm did not include documentation of the corrections and corrective actions and your firm did not provide evidence of implementation. Therefore, FDA cannot make an assessment with respect to adequacy.
 
6.    Failure to establish and maintain procedures to control all documents that are required by this part, as required by 21 CFR 820.40. For example, your firm’s Document Control Procedure, RA-QP-01, does not require a review/change in procedures when changes to processes occur. Specifically, your firm opened a non-conformance, AB10010, on July 26, 2010 and the corrective action was to change the label inspection sampling plan. However, there is no evidence that the procedure was updated and there is no documentation to show that the updated process is being completed. 
 
We reviewed your firm’s response and conclude that is not adequate. Your firm noted that it will revise the “Standard Operation Procedure for Incoming Outer Packages and Labels Inspection” in order for the inspection to be conducted according with the SOP. In addition, your firm noted that it will train the incoming materials inspectors according to the revised SOP. However, your firm did not specify that it will revise its document control procedure to include requirements for reviewing and updating procedures when changes to processes occur. In addition, your firm did not include a plan and evidence of implementation of a corrective action including a retrospective review of other procedures.
 
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 awarding of contracts.  Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations 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, as well as 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 (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 #409147 when replying. If you have any questions about the contents of this letter, please contact: Ronald L. Swann at 301-796-5770.
 
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