Inspections, Compliance, Enforcement, and Criminal Investigations

The See Clear Company 2/14/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Atlanta District
60 Eighth Street NE
Atlanta, GA 309071-2721 

 

February 14, 2017 
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
 
Da Young Kim, CEO
The See Clear Company
4995 Buford Hwy Ste 102
Norcross, GA 30071-2721
 
WARNING LETTER
17-ATL-04
 
Dear Mrs. Kim:
 
During an inspection of your firm located in Norcross, Georgia,on October 21, 2016, through November 4, 2016, our investigators from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of soft contact lenses for daily wear under the brand names Circle Collection, Diamond, Fierce, Fright, Ambition, See Clear, See Clear Color and Lunatic.
 
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 any function of the body.
 
The current 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 (CGMP) requirements of the Quality System regulation (QSR) found at Title 21, Code of Federal Regulations (CFR), Part 820. 
 
We received on November 25, 2016, your firm’s written response concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, that was issued to you at the closing of the inspection. Your firm’s response included a narrative response with a plan to complete corrections to address the Inspectional Observations but did not include documents or evidence of the completion of such corrections. We address your firm’s 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 action, as required by 21 CFR 820.100(a). Specifically, your Untitled (CAPA) procedure, (b)(4), does not include verifying or validating the corrective and preventive action, and implementing and recording changes in the methods and procedures.
 
We reviewed your firm’s response where it’s stated that your firm will revise the firm’s CAPA procedures to include verifying or validating the corrective and preventive actions, and implementing and recording changes in the methods and procedures, in addition to Perform a systemic (i.e., system wide) review of the firm’s CAPA procedures in order to identify other CAPA procedural nonconformities that may exist.
 
However, the adequacy of your firm’s response and/or proposed actions cannot be determined at this time. Your response does not include supporting documentation to demonstrate that the corrections have been completed. These planned actions cannot be evaluated without supporting documentation. 
 
2.    Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your firm’s procedure, Customer Satisfaction Procedure (b)(4), describes a customer survey that is (b)(4) to the customers to rate the company and its products. However, this document does not cover procedures for receiving, reviewing, and evaluating customer complaints or to determine when an investigation is necessary; nor addresses appropriate customer complaint handling and complaint file maintenance.   
 
We reviewed your firm’s response and acknowledge that your firm will update the complaint handling procedure to comply with the established regulation requirements and will conduct a systemic (i.e., system wide) review of the firm’s complaint handling procedures in order to identify other complaint handling procedural nonconformities that may exist.
 
The adequacy of your firm’s response and/or proposed actions cannot be determined at this time.  Your response does not include supporting documentation to demonstrate that the corrections have been completed. These planned actions cannot be evaluated without supporting documentation. 
 
3.    Failure to establish procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). Specifically, your firm does not have an established procedure for acceptance of incoming product (contact lenses) nor document acceptance and rejection of incoming product.
 
We reviewed your firm’s response and conclude that its adequacy cannot be determined at this time. In response to this violation, your firm stated that will establish (define, document, and implement) acceptance procedures in accordance with regulations. However, supporting documentation to evaluate your proposed correction was not included in your response.
 
4.    Failure to maintain distribution records, as required by 21 CFR 820.160(b). Specifically, your firm was unable to provide distribution records which include or refer to the location of: (1) name and address of the initial consignee; (2) identification and quantity of devices shipped; (3) date shipped; and (4) any control number(s) used.
 
We reviewed your firm’s response and conclude that adequacy of your firm’s response and/or proposed actions cannot be determined at this time. In your response you state that your firm will establish (define, document, and implement) procedures, including recordkeeping, for distribution controls in accordance with the regulations. Nonetheless, your response does not include supporting documentation to demonstrate that the corrections have been completed.
 
5.    Failure to clearly define the type of extent of control to be exercised over contractors, as required by 21 CFR 820.50 (a)(2).  Specifically, the agreement between your firm and your contract manufacturer for soft daily wear contact lenses does not include a description of the quality requirements that must be met by your contractor. Additionally, you were unable to provide audit procedures or documents that demonstrate conformance with 21 CFR 820.50.
 
We acknowledge that your firm is planning to (1) establish a quality agreement that properly outlines the roles and responsibilities between your firm and its contract manufacturer(s), (2) establish adequate documentation of the monitoring of your firm’s contract manufacturer(s), if necessary including re-evaluation of the contract manufacturer(s), (3) review and, as necessary, clearly define the type and extent of control to be exercised over all other of your firm’s contractors and (4) establish adequate documentation of the monitoring of your firm’s other contractors.
 
Nonetheless, the adequacy of your firm’s proposed actions cannot be determined at this time.  Your written response does not include supporting documentation to demonstrate that the corrections have been completed. 
 
6.    Failure to adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically, your firm’s procedure (b)(4) for handling of non-conforming product does not reflect current activities performed at the time of occurrence. For example, your procedure states, “Nonconforming product is moved back to the staging area and documented on the Device History Record for scrap.” During the inspection, firm’s management stated that all Device History Records are located at your contract manufacturer site and were not readily available at your firm.
 
We reviewed your firm’s response and acknowledge it states that firm’s procedures will be revised for handling nonconforming product so as to include procedures for documentation, evaluation, segregation, and disposition of nonconforming product. Also, your firm will perform a systemic (i.e., system wide) review of firm’s nonconforming product procedures in order to identify other procedural nonconformities that may exist. However, the adequacy of your firm’s proposed actions cannot be determined at this time.  Your response does not include supporting documentation to demonstrate that the corrections have been completed. 
 
7.    Failure to adequately maintain a device history record, as required by 21 CFR 820.184. Specifically, your firm was unable to provide a complete Device History Record for the entire quantity of Diamond Brand soft contact lenses Lot No. E28Hjwf.
 
We acknowledge that your firm is planning to review for completeness and approve prior to product release the DHR’s for any work currently in progress at the contract manufacturer. However, the adequacy of your firm’s response and/or proposed actions cannot be determined at this time.  Your response does not include supporting documentation to demonstrate that the corrections have been completed.
 
8.    Failure to document the dates of quality audits, as required by 21 CFR 820.22. Specifically, your firm was unable to provide the dates of the quality audits for 2014, 2015, and 2016.   
 
We reviewed your firm’s response and acknowledge that your response states that your firm will perform and document a quality audit and will review and as necessary revise its written quality audit procedures in order to assure consistent execution and documentation of future quality audits.
 
The adequacy of your firm’s response and/or proposed actions cannot be determined at this time.  Your response does not include supporting documentation to demonstrate that the corrections have been completed. 
 
9.    Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals as required by 21 CFR 820.20(c). Specifically, the firm’s management was unable to provide the dates, agendas and attendance records for the 2014 and 2015 management review meetings.
 
We reviewed your firm’s response and acknowledge that it states that your firm will perform and document a management review and will review and as necessary revise its written management review procedures in order to assure consistent execution and documentation of future management reviews.
 
However, the adequacy of your firm’s response and/or proposed actions cannot be determined at this time. Your written response does not include supporting documentation to demonstrate that the corrections have been completed. 
 
10.    Failure to document personnel training as required by 21 CFR 820.25(b). Specifically, your firm was unable to provide documented training records for the employees.
 
We acknowledge that your firm is planning to (1) Identify personnel training needs and then create corresponding training plans to assure that personnel have the necessary training; (2) Complete and document personnel training in accordance with the aforementioned training plans; and (3) will review and as necessary revise it’s written procedures for the personal training in order to assure consistent documentation of future personnel training.
 
However, the adequacy of your firm’s response and/or proposed actions cannot be determined at this time. Your response does not include supporting documentation to demonstrate that the corrections have been completed. 
 
11.    Failure to include in the documentation of approval of the documents, the approval date and the signature of the approving official as required by 21 CFR 820.40(a). Specifically, several quality procedures reviewed during the inspection of your firm were found without the approval date and approving official signature.
 
We reviewed your firm’s response and acknowledge that it states that your firm will (1) document the approval date and the signature of the approving official for all quality system documents required to be controlled and (2) review and as necessary revise it’s written document control procedures in order to assure consistent execution and documentation of future document approval. However, the adequacy of your firm’s response and/or proposed actions cannot be determined at this time.  Your response does not include supporting documentation to demonstrate that the corrections have been completed.
 
Additionally, we acknowledge that your response states that your firm has hired an outside contractor to evaluate firm’s quality system and implement corrective actions and that you have initiated corrections to mitigate the health risk that may represent products in the market. Your response will be maintained on file as a record of your firm’s efforts to correct the deficiencies noted by the investigator.  A complete evaluation of the effectiveness of the actions taken will be made during the next inspection of your facility.
 
Your firm should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, 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 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 (15) 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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Your firm’s response should be sent to the attention of:
 
Derek Price
Director of Compliance
U.S. Food and Drug Administration
Atlanta District
60 Eighth Street NE
Atlanta, GA 309071-2721
 
If you have any questions about the contents of this letter, please contact: Compliance Officer Dayna I. Martinez at 787-729-8608 or via email at dayna.martinez@fda.hhs.gov.
 
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,
/S/ 
Ingrid Zambrana
District Director
Atlanta District Office
Southeast region, Office of Regulatory Affairs
U.S. Food and Drug Administration

 

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