Soleetech Corporation 8/13/13
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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
August 13, 2013
VIA UNITED PARCEL SERVICE
Mr. Hsiao Ching Tang
No 4, Alley 24,
Lane 227 Ming Tzu Road
Dear Mr. Tang:
During an inspection of your firm located in Taipei, Taiwan, on May 13, 2013 through May 15, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures airway (extension) connectors. 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. 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). For example, your firm stated to the FDA investigator that it does not have a procedure for CAPA and has no plan for developing a CAPA procedure.
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 stated to the FDA investigator that it has no procedure for complaint handling and no procedures for the documentation and storage of non-conforming material until disposition.
3. Failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm stated to the FDA investigator that it has no procedure for complaint handling and no has plan for developing a complaint handling procedure.
4. 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, your firm stated to the FDA investigator that it has no procedures for establishing production and process controls, to ensure that a device conforms to its specifications.
5. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example, your firm stated to the FDA investigator that it has no procedures for the identification, approval, implementation, and change of quality documents. Your firm’s Outgoing Inspection Form for the (b)(4) and the (b)(4) does not have a control number or a version number. Additionally, your firm uses an (b)(4) to document production specifications for the (b)(4).
6. Failure, where appropriate, to establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics, as required by 21 CFR 820.250(a). For example, your firm stated to the FDA investigator that it has no procedures for identifying and implementing valid statistical techniques.
7. Failure to establish and maintain procedures to ensure that Device History Records (DHR’s) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR), as required by 21 CFR 820.184. For example, your firm stated to the FDA investigator that is does not maintain device history records. Production information is recorded on the (b)(4). However, (b)(4). The data from the previous production run is not stored (b)(4).
8. Failure to establish and maintain 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. These quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22. For example, your firm stated to the FDA investigator that it has no procedures for conducting, documenting, and reviewing quality audits.
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 device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm stated to the FDA investigator that it does not have any procedures for submitting MDRs and has no plan for developing a procedure for MDR reporting.
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 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 # 408340 when replying. If you have any questions about the contents of this letter, please contact: Carl Fischer, Ph.D. at
301-796-5770 or 301-847-8137.
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.
Steven D. Silverman
Office of Compliance
Center for Devices and