| Public Health Service Food and Drug Administration |
10903 New Hampshire Avenue |
Department of Health and Human Services
FEB 03 2011
WARNING LETTER
Via United Parcel Services
Mr. Yu Zhu Ding
President and General Manager
AID United International Co. Limited
c/o Mr. Keith Qui
U.S. Agent for AID United International Co. Limited
Widthman USA, Inc.
4 Delaware Dr.
East Brunswick, New Jersey 08816.
Dear Mr. Ding:
During an inspection of your firm located in Yangzhou City, China on September 27.2010 through September 29, 2010, investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures class I medical devices including adhesive bandages and first aid kits. 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to maintain adequate complaint files. Failure to establish and maintain adequate procedures for receiving, reviewing and evaluating complaints, as required by 21 CFR 820.198(a).
For example:
a. When the investigator asked to review your customer complaint files, Mr. Wang, your Sales Manager who facilitated the inspection and translated documents to English, indicated that your firm resolved all shipping complaints on the spot and did not document these as complaints in the complaint handling system. Shipping complaints are not being processed like other complaints
b. Your complaint handling procedure did not include provisions for reviewing each complaint for the need to be filed as a medical device report and your complaint handling form did not include a spot for recording the decision of whether or not the complaint was MDR reportable.
2. Failure to establish and maintain adequate procedures to adequately control environmental conditions where environmental conditions could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c).
For example, your firm has an environmentally controlled room where it manufactures and packages adhesive bandages. However, your firm's procedures do not define the classification of the room. The investigator's review of your firm's environmental monitoring records for the room showed that your firm does not test for particulates in the room. Your firm performs temperature and humidity checks on a daily basis and testing every (b)(4) for bioburdens on surfaces and employees' hands. Your firm's environmental control procedure does not define how often testing is to be performed in the environmentally controlled room.
3. Failure to establish and maintain adequate procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained, as required by 21 CFR 820.72(c).
For example, when the investigator asked to review the calibration records for the temperature gauges on the (b)(4) and (b)(4) (ovens used for incubation of microbiological test plates for bioburden testing) that were included on your listing of equipment that is required to be calibrated, Mr. Wang, your Sales Manager, was unable to provide calibration records for these gauges. There was no documentation to show that calibrations have been performed for all equipments that require calibration, including the (b)(4) and (b)(4).
4. Failure to maintain an adequate device master record (DMR), as required by 21 CFR 820.181.
For example, your firm performs bioburden testing on devices but when the investigator asked Mr. Wang, your Sales Manager, how the tests were performed, he responded that your firm did not have written procedures on how to perform bioburden testing. Your firm did not have formal procedures for their production methods and production procedures documented in the DMR.
5. Failure to maintain adequate device history records (DHRs). Failure to establish and maintain adequate procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of 21 CFR 820, as required by 21 CFR 820.184.
For example:
a) The device history record for the adhesive bandages, lot numbers (b)(4) and (b)(4) does not show that the bioburden testing was performed according to ISO 11137-1, the standard your firm indicated you followed for bioburden testing of these adhesive bandages. The record only indicates the final bioburden result, and does not include the results of the incubation times and temperatures as required by ISO 11137-1.
b) When asked by the investigator if your firm keeps copies of labeling for each production lot for your adhesive bandages, Mr. Wang, your Sales Manager, indicated that you did not keep copies. The device history records for the adhesive bandages do not include copies of the labeling of each production unit of your finished devices.
6. Failure to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR 820 and the manufacturer's established quality policy and objectives by management with executive responsibility, as required by 21 CFR 820.20(c).
For example, when our investigator asked Mr. Wang, your Sales Manager, if your firm had procedures for performing management reviews, Mr. Wang was unable to provide one, but promised to implement procedures for conducting management reviews.
Our inspection also revealed that your 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 (MDR) regulation. Significant deviations 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.
A follow up inspection will be required to assure that corrections are adequate. We will contact the appropriate people and request an establishment reinspection. An FDA trip planner will be in touch with you to arrange a mutually convenient date for this inspection.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801 (a) of the Act (21 U.S.C. § 381 (a)). Also, U.S. federal agencies are advised of the issuance of all 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 (15) working 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 you plan to prevent these violation(s), or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to: Field Operations Branch, Office of Compliance, Center for Devices and Radiological Health,1 0903 New Hampshire Ave, Building 66, Silver Spring, MD 20993. If you have any questions about the content of this letter please contact: Valerie A. Flournoy 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 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, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/s/
Steven D. Smith
Director
Office of Compliance
Center for Devices and
Radiological Health
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