| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
NOV 07 2011
WARNING LETTER
VIA UNITED PARCEL SERVICE
Mr. Joseph Lu
General Manager
Vega Technologies, Inc.
11f-13, 100 Chang-Chun Road
Taipei, Taiwan 104
Dear Mr. Lu:
During an inspection of your firm located in Dongguan City, Guangdong, China, on June 13, 2011, through June 16, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures nebulizers and thermometers. 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 July 12, 2011, 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 establish and maintain adequate procedures for validating the device design, as required by 21 CFR 820.30(g).
For example:
a. Your firm did not adhere to its procedure for performing design risk analysis. Specifically, the Risk Management Procedure (R205, Rev. 1, dated 10/19/2009) includes a description of the method to be used for risk management. The design history file for the SU-01 suction pump included a risk analysis that was performed using a different method than that required by the procedure.
We reviewed your firm's response and conclude that it is not adequate. The response indicates that the risk analysis was made by a professional consultant according to (b)(4), while the Risk Management Procedure R205 has not been updated to make reference to (b)(4). The response provided the R205 procedure (Rev. 2, 06/28/2011) and its associated forms revised ("(b)(4)," Form R447-2; "(b)(4)," Form R448-2) to make reference to instead of (b)(4). However, your firm has not ensured that training for the correct risk analysis tool was completed.
b. Acceptance criteria were not established prior to the performance of validation activities. Specifically your firm did not define acceptance criteria for the design validation activities for its SU-01 suction pump.
We reviewed your firm's response and conclude that it is not adequate. The response indicates that the R203 Design Control Management Procedure has been revised to establish related acceptance criteria prior to the performance of validation activities. The response also indicates that Section 5.5 of this procedure defines specifications of design input, as well as sets up methods of validation and acceptance criteria. The response provided the revised Design Control Management Procedure (R203 Rev. 10, 06/28/2011). However, this procedure is written in Chinese and there is no English translation. Please provide an English translation for this R203 document for our review. In addition, the response does not describe what was done to ensure that the SU-01 suction pump design met design validation requirements, if other designs were reviewed to determine whether design validation criteria were established prior to design validation, and what actions were taken if other design validation criteria were not established prior to design validation.
2. Failure to establish and maintain adequate procedures for verifying the device design, as required by 21 CFR 820.30(1). For example, design verification did not confirm that the design output meets the design input requirements. Specifically, there was no design verification for the SU-01 suction pump to show that the design outputs met the design input requirements.
We reviewed your firm's response and conclude that it is not adequate. The response indicates that the R203 Design Control Management Procedure has been revised to ensure the design output meets the design input requirements. The response also indicates that Section 5.10 of this procedure adds verification methods, test data, and evidence, which are documented on the R440-2 (b)(4). The response provided the revised Design Control Management Procedure (R203, Rev. 10, 06/28/2011) and its associated form (b)(4)," Form R440-2, Rev. 2, 06/28/2011). However, the procedure and its associated form are written in Chinese and there is no English translation. Please provide an English translation for these documents for our review. In addition, training was not completed for the revised verification procedure. Your firm did not retrospectively conduct verification activities for the SU-01 suction pump or determine if other projects required verification activities to be completed.
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, there is inadequate documentation of the effectiveness of corrective and preventive actions.
For example:
a. CAPA 100071, opened in response to customer complaint CC-473 for master cartons and gift boxes being deformed when the product was shipped, indicates for effectiveness that there were no complaints received for the failure. The effectiveness date is the same date as the implementation of the CAPA. No time was given to receive feedback from customers. In addition, the CAPA required that (b)(4). There was no documentation showing that the procedures for delivery and loading management were updated to include the loading requirements.
We reviewed your firm's response and conclude that it is not adequate. The response indicates that the Q208 Corrective and Preventive Action Management Procedure has been revised to define the effectiveness of corrective and preventive action before the CAPA is closed. Section 5.6 of the procedure prescribes that QE personnel must check (b)(4) and confirm (b)(4). The implemented measures can then be determined effective and the CAPA can be closed. The response provided the revised Corrective and Preventive Action Management Procedure (Q208, Rev. 9, 06/20/2011); however, it is written in Chinese and there is no English translation. The loading requirements are addressed in your firm's response to Observation 46 of the FDA 483 (i.e., item 3b below). Please provide an English translation of this document for our review. In addition, training was not completed for the revised Corrective and Preventive Action Management Procedure. Furthermore, your firm did not complete a retrospective review of CAPAs to ensure that other CAPAs have had adequate effectiveness evaluations.
b. CAPA 10041, opened in response to customer complaint CC396 for mixed products in one master carton, indicates for effectiveness that the CAPA was carried out and that there were no problems. The effectiveness date is the same date as the implementation of the CAPA. No time was given to allow for feedback from the customers.
We reviewed your firm's response and conclude that it is not adequate. The response indicates that the P216 Shipping Operation Management Procedure has been revised to add an SOP of container loading. Section 5.4 of the procedure specifies that (b)(4) The response provided the revised Shipping Operation Management Procedure (P216, Rev. 2, 06/20/2011); however, it is written in Chinese and there is no English translation. The effectiveness of corrective and preventive action is addressed in your firm's response to Observation 4A of the FDA 483 (i.e., item 3a above). Please provide an English translation of this P216 document for our review. In addition, training was not completed for the revised P216 Shipping Operation Management Procedure. Furthermore, your firm did not complete a retrospective review of CAPAs to ensure that other CAPAs had adequate effectiveness evaluations.
4. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically, the device history record for order number (b)(4) indicates that the firm conducted sampling of finished devices for visual inspection prior to release to the warehouse for shipment to the customer. The sampling was performed on quantities of (b)(4) devices. Sampling was performed according to an (b)(4) sampling table that required (b)(4) devices to be inspected with acceptance at (b)(4) and rejection at (b)(4) There were (b)(4) quantities that had (b)(4) reject in each of the (b)(4). The rejected samples were replaced and the quantities were released for shipment. The (b)(4) device quantities were not rejected.
We reviewed your firm's response and conclude that it is not adequate. The response indicates that the defect was a very little scratch on the box and was considered a "(b)(4). The Q417-1 QC Inspection Standard of Nebulizer CN-02MX did not define the (b)(4) in detail for master cartons and gift boxes. The response also indicates that this standard has been revised to make clear the definition of "(b)(4)" defects for cartons and gift boxes; therefore, the inspector can make a correct judgment accordingly. The response provided the revised QC Inspection Standard of Nebulizer CN-02MX (Q417-2, Rev. 2, 06/23/2011); however, it is written in Chinese and there is no English translation Please provide an English translation f this Q417-2 document for our review. In addition, training was not conducted for the revisions to the Q417-2 QC Inspection Standard. Furthermore, your firm did not complete a retrospective review of other lots to ensure that they were released appropriately.
Please provide an English translation of the revised 0219 MDR Management Procedure for our review.
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 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 Avenue, Silver Spring, MD 20993. Refer to CMS case #223154 when replying. If you have any questions about the contents of this letter, please contact: Mr. Charles Cathlin at phone (301) 796-5548 or fax (301) 847-8128.
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 assurance 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.
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
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