Interojo Inc. 1/7/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
January 7, 2013
VIA UNITED PARCEL SERVICE
Mr. Si-Chul Rho
Chief Executive Office and President
Pyeongtaek, South Korea
Dear Mr. Rho:
During an inspection of your firm located in Pyeongtaek, South Korea, on September 24, 2012, through September 27, 2012, 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), 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 are intended 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 October 09, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that 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 document, for validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual performing the process or the major equipment used, as required by 21 CFR 820.75(b)(2). For example:
a) Your firm’s “Bio-burden Test Reports,” dated January 24, 2010, June 16, 2011, January 13, 2011, June 10, 2011, January 13, 2012, and June 20, 2012, specify that bacterial samples should be incubated in (b)(4) at (b)(4)ºC for (b)(4) days and fungi samples should be incubated in (b)(4) at (b)(4)ºC for (b)(4) days. However, your firm did not document, on the same test reports, the date and time that each sample was placed into and removed from the incubator. Additionally, there was no documentation of the incubation temperatures for any of these samples.
b) Your firm’s procedure, “Soft Contact Lens Sterilizer,” PI-512-03, Rev. No. 1, specifies that each sterilizer load includes (b)(4) bioindicators and that the results of the bioindicators are to be reported in the “Product Test Report,” which is completed prior to the release of the product for distribution. However, the inspection revealed that the positive and negative controls and the incubation temperature for the bioindicators were not documented in the “Product Test Reports” dated (b)(4).
c) Your firm’s autoclave re-validation data, “Performance Qualification Summary Report for Autoclave,” Model FOAF5/A, Serial No. (b)(4), document no. PQS-AC-FOAF5/A-01, effective date (b)(4), revealed the (b)(4). However, the investigator observed that the (b)(4). Furthermore, the investigator noted that (b)(4).
We reviewed your firm’s response and concluded that it is not adequate. Your firm established a “Bioburden & Sterility Test Working Instruction,” Doc. No. SI-114, an “Incubator Logbook,” Doc. No. SI-114-1, and the “Operation of Incubator Forms,” Doc. Nos. PI-512-06, PI-512-07, PI-512-08, and PI-512-09, in order to properly record the sample’s incubation date, time, user, and purpose. In addition, your firm established the “Incubation Logbook,” Doc. No. SI-114-2, the “Photos of Test Results,” Doc. No. SI-114-4, and the “Check Table During Sterility Test,” Doc. No. SI-114-5, in order to record the testing type, lot number, purpose, time, control photos of test result, and to check and evaluate test elapsed time. Also, your firm established the “Temperature Record of Incubator,” Doc. No. SI-114-3, in order to record equipment number, purpose, date, time, and temperature, and the “Bio-indicator Loading Pattern Procedure,” Doc. Nos. PI-512-04 and PI-512-05. Finally, your firm noted that it trained its staff on the newly established documents and related forms. However, your firm did not provide a description and evidence of implementation of corrective actions to include a review and analysis of the previous bio-burden and product test reports, and the review of other testing procedures.
2) Failure to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, your firm’s procedure, “Design Management,” OP-702, Section 7.1, states that the “Design Review Committee” would approve all changes in the design. However, the “(b)(4)” design report was approved by your firm’s Quality Assurance Representative and not by the “Design Review Committee,” as specified in your firm’s procedure OP-702.
We reviewed your firm’s response and concluded that it is not adequate. Your firm noted that the design change document for the (b)(4) will be completed and approved according to the recently established design control procedure by December 2012. However, your firm did not provide a description and evidence of implementation of corrective action to include a review and analysis of the previous design change reports and the review of other documents requiring approval.
3) Failure to establish and maintain adequate procedures to control labeling activities, as required by 21 CFR 820.120. For example, your firm’s bulk labels are stored (b)(4). In addition, your firm stated that there are (b)(4). However, during the inspection, the investigator noted that at (b)(4).
We reviewed your firm’s response and concluded that it is not adequate. Your firm did not provide any description or necessary information, to include evidence of implementation, of the correction and the corrective action.
Given the serious nature of the violations of the Act, contact lensesmanufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, 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 you have 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 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 action 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 # 315618 when replying. If you have any questions about the contents of this letter, please contact: Ronald L. Swann, Branch Chief, Dental, ENT, and Ophthalmic Device Branch at 301-796-5770, or firstname.lastname@example.org.
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 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 to bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Device and