| Public Health Service Food and Drug Administration |
10903 New Hampshire Ave |
Department of Health and Human ServicesWARNING LETTER
December 22, 2010
VIA UPS EXPRESS
Mr. Gao Fei
General Manager
Abon Biopharm (Hangzhou) Co. Ltd.
#198 12th Street East
Hangzhou Economic & Technological Development Area
Hangzhou, China 310018
Dear Mr. Gao:
During an inspection of your firm located in Hangzhou, China on September 19, 2010 through September 21, 2010, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures various rapid test kits including fertility tests (pregnancy-hCG, ovulation-LH, menopause-FSH), infectious disease (Strep A, mononucleosis, H. pylori), tumor marker (fecal occult blood), drug of abuse (oxycodone-OXY, phencyclidine-PCP, propoxyphene-PPX, marijuana-TCH, tricyclic antidepressants-TCA, ecstasy-MDMA, morphine-MOP, opiate-OPI, methadone-MTD, amphetamine-AMP, barbiturates-BAR, buprenorphine-BUP, benzodiazepines-BZO, cocaine-COC, methamphetamines-MET, EDDP, ketamine-KET, methaqualone-MQL). 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. We received a response from Ms. Pang Qi, Senior Quality Director, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. 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 adequately ensure that, when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
For example: The majority of the finished products require storage at temperatures of (b)(4)°C; however, the temperature control of the (b)(4)m2 storage warehouse has not been adequately validated. There was no documentation of the volume of material stored in the warehouse during validation. There was no documentation of how many air conditioning (A/C) units were turned on or what the settings of these A/C units were. There was no documentation of how many thermometers were to be placed or where in the warehouse should these be placed based on, for example, height of placement and proximity to A/C units or direct air flow. There was no documentation as to whether the warehouse window curtains were all opened, or some were opened during validation.
We reviewed your response and concluded that the adequacy of the response cannot be determined at this time because a revised validation protocol was not provided and a validation report will not be available until after July 2011.
2. Failure to adequately establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed, as required by 21 CFR 820.250(b).
For example: The firm has established a company policy titled “Statistical Sampling Quality Control Inspection and Testing of Semi Finished and Final Products” based on a standard for “Sampling Plans for Inspection by Attributes”, ANSI/ASQC Z1.4, that requires 80 samples for final product QC testing to satisfy a Special Inspection Level S4. However, Final Testing Procedures for various class II devices including (b)(4) hCG pregnancy test devices state that a sample of 80 should be divided among (b)(4) different tests. The Final Testing Procedures do not comply with the firm’s sampling policy because a sample of less than 80 would be tested for each attribute.
We reviewed your response and concluded that the adequacy of the response cannot be determined at this time because a revised sampling plan based on a valid statistical rationale and adequate final testing procedures were not provided.
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, 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 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. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to:
James L. Woods
Deputy Director for Patient Safety and Product Quality
Food and Drug Administration
Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH
WO66 RM5688
10903 New Hampshire
Silver Spring, MD 20993
If you have any questions about the content of this letter please contact: Ileana Elder at (301) 796-6143.
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/
Alberto Gutierrez
Director
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and
Radiological Health
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