Sure On Industries Ltd. 8/6/12
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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 6, 2012
VIA UNITED PARCEL SERVICE
Sure On Industries Ltd.
Bldg. 2, Zhu Fo Ling
168 Industrial Area, Tang Xia
Dong Guan City, China
Dear Mr. Wen:
During an inspection of your firm located in Dong Guan City, China, on May 28 through May 31, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures non-sterile surgical pleated masks, respirators (including N95 Healthcare Particulate Respirators), and examination gowns. 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 Michael Huang on June 15, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. This response is not adequate because it states that your firm’s “CAR reports” for the 6 observations will be submitted before the end of July 2012. No additional information regarding systemic corrective actions has been provided. The violations identified during the inspection include, but are not limited to, the following:
1. Failure to establish adequate procedures to ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance, as required by 21 CFR 820.75(a). For example, process validation activities and results have not been adequately documented and approved. Specifically, your firm has no written process validation protocols and reports for the (b)(4) operations for the N95 particulate respirators.
2. Failure to establish and maintain procedures for validating the device design, including software validation and risk analysis, where appropriate, as required by 21 CFR 820.30(g). For example, your firm has a written procedure for design controls, SQ2-04200; however, it does not describe the requirement for risk analysis.
3. Failure to establish and maintain procedures for finished device acceptance to ensure that each procedure run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example:
A. The procedure for (b)(4)
B. The sampling method for testing finished devices was not followed and documented to ensure that representative samples are collected from multiple lots, as required by the Procedure for Sampling, SQ3-10101. (b)(4)
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 has no (b)(4)
5. Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, (b)(4)
6. 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 this part, as required by 21 CFR 820.184.
For example, the review of two DHRs indicates that the following (b)(4) tests were conducted prior to the manufacture of the lots:
Material Lot Number Date of manufacture Date of (b)(4)
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 devices 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 has no written procedure for Medical Device Reports.
A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.
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 # 319538. If you have any questions about the contents of this letter, please contact: LaShanda Long 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.
Steven D. Silverman
Office of Compliance
Center for Devices and