| Public Health Service Food and Drug Administration |
Los Angeles District |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
November 24, 2010
W/L 14-11
Mr. Andy Chao
President
Eagle Health Supplies, Inc.
535 W Walnut Ave
Orange, CA 92868
Dear Mr. Chao:
During an inspection of your firm located in Orange, CA on July 14 through July 26, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer, initial importer and distributor of disposable 4-O2 CPR Mouth Barriers. 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 establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example, according to your firm’s management, Corrective and Preventive Action (CAPA) procedures have not been established. Your firm’s management stated that they were not aware of the CAPA requirements of 21 CFR 820.100.
2. Failure to 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 has not established complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
For example, your firm imports devices (including the 4-O2 Disposable CPR Mouth Barrier) from contract manufacturers overseas. There are no procedures to ensure these suppliers are: (1) evaluated and selected based on their ability to meet specified requirements, including quality requirements; and, (2) controlled based on evaluation results. According to your firm’s Manager of Operations, your firm does not require its suppliers to provide finished device acceptance records or certifications of compliance to specified requirements.
4. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a).
For example:
A. Your firm does not have documented receiving acceptance procedures or document receiving acceptance activities for the 4-O2 Disposable CPR Mouth Barrier (or any other device); and, B. Your firm has not established finished device acceptance procedures for the 4-O2 Disposable CPR Mouth Barrier (or any other device).
5. 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 does not have an established procedure to control design changes for the 4- O2 Disposable CPR Mouth Barrier (a Class II device).
6. Failure to maintain device master records (DMRs), as required by 21 CFR 820.181.
For example, during the inspection, you stated that your firm had drawing specifications which you provided to contract manufacturers, but during the inspection none of the cited drawings were presented to the investigator.
7. Failure to maintain Device History Records (DHRs), as required by 21 CFR 820.184.
For example, your firm does not maintain Device History Records (DHRs) for the 4-O2 Disposable CPR Mouth Barrier (or any other device).
8. Failure to establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40.
For example, your firm does not have any document control procedures.
9. Failure of management with executive responsibility to review the suitability 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, as required by 21 CFR 820.20(c).
For example, according to your firm’s management, your firm does not conduct management reviews and has not established management review procedures.
10. Failure to establish quality system procedures and instructions, as required by 21 CFR 820.20(e).
For example, according to you, your firm does not have quality system procedures.
11. Failure of management with executive responsibility to establish its policy and objectives for, and commitment to, quality, as required by 21 CFR 820.20(a).
For example, according to you, your firm has not established a quality policy.
This inspection also revealed that these devices are misbranded within the meaning of section 502(t)(2), of the Act (21 U.S.C. § 352(t))(2), in that your firm failed or refused to furnish any material or information respecting the device that is required under section 519, 21 U.S.C. 360i, and 21 CFR Part 803 (Medical Device Reporting regulation).
12. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
For example, according to your firm’s management, there are no written MDR procedures.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, 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 violation(s), 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.
Your response should be sent to:
Blake Bevill
Director, Compliance Branch
US Food & Drug Administration
19701 Fairchild, Irvine, CA 92612-2446
If you have any questions about the content of this letter please contact: Mei-Chen (Jessica) Mu at 949-608-4477.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) 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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Sincerely yours,
/S/
Alonza E. Cruse
District Director
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