Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
August 20, 2010
1268 N Lakeview Ave
Anaheim, CA 92807-1831
Dear Dr. Chen:
During an inspection of your firm located in Anaheim, California on March 24 through April 26, 2010, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Teco Diagnostics UriTek TC-101 Urine Strip Reader and 10SGL Clinistrip Urine reagent strip, (b)(4) Urine Strip Reader and 10SG urine strips. 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 Mr. Sajid M. Azhar, Quality Systems Manager dated June 2, 2010 concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you, Dr. KC Chen. We have not addressed this response below in relation to each of the noted violations because this response was not received within 15 business days of the close of the inspection. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action that include requirements for identifying the actions needed to correct and prevent recurrence of non-conforming product and other quality problems as required by 21 CFR 820.100(a)(3). For example, a CAPA was opened to address a discrepancy in patient information input and output from the device. The root cause documented was attributed to being over looked by the Quality Assurance during QC/QA. The corrective action called for retraining of the QC/QA staff on the revised QC/QA procedure. The revised procedure does not specify the need to check for patient identification inputs and outputs since this is what was not being performed.
2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action that include requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).
For example, Corrective and Preventive Action, Procedure Number: (b)(4) does not address verification or validation of the corrective and preventive actions to ensure its effectiveness.
3. Failure to adequately establish and maintain procedures for monitoring and control of process parameters for validation processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b).
For example, the re-validation of the (b)(4) Dryers (b)(4) was not fully documented or performed to establish speed parameters. The operating chart for the (b)(4) Dryer (b)(4) specifies a speed of (b)(4) with a temperature of (b)(4). However, the revalidation in 2009 documented the speed was set at (b)(4) with a temperature of (b)(4); process parameters were not controlled. Also, the protocol did not specify the operating speed or temperature for the (b)(4) Dryers (b)(4).
4. 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, Customer Complaints/Customer Feedback, Procedure Number: (b)(4) was not being followed. Specifically,
a) The firm’s Customer Complaints and Customer Feedback procedure requires the Quality Assurance Manager or Laboratory Supervisor to complete section VII on form (b)(4). Of the documents reviewed the forms were signed off by individuals other than the Quality Assurance Manager or Laboratory Supervisor.
b) The procedure requires for individuals to complete section I-VI on the complaint form (b)(4). One form did not specify whether the product was supplied or manufactured and 1 form did not specify the complaint number.
5. Failure to maintain adequate record of the investigation by the formally designated unit identified in paragraph (a) of this section, when an investigation is made, that shall include any device identification and control numbers used and the nature and details of the complaint, as required by 21 CFR 820.198(e)(3) and (5).
a) Complaint number (b)(6), the description does not specify whether the urine strips were used alone or in conjunction with a urine analyzer when the false positives were observed by the customer. Only the lot numbers of the urine strips are recorded on the complaint report. The serial number of the analyzer is not recorded.
b) Complaint number (b)(6), the description does not specify whether the strips were used alone or in conjunction with a competitor’s urine analyzer when false positives in ketones were observed.
c) Complaint number (b)(6), the description does not specify the strips lot number in use with the urine analyzer when it failed to detect blood and trace positive results were not reading consistently.
6. Failure to establish and maintain procedures to ensure that the device history record 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 and shall include or refer to the location of any device identification(s) and control number(s) used, as required by 21 CFR 820.184(f).
For example, Of the 11 device history records reviewed for urine strips (b)(4), the identification numbers of the (b)(4) dryers used to dry the strips were not specified.
7. Failure to establish and maintain adequate procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed as required by 21 CFR 820.150(a).
a) Ten bottles of the firm’s and a supplier’s diluents for (b)(4) and with expiration dates (b)(4) were on a shelf in the raw material release section of the warehouse.
b) One bottle of the firm’s labeled diluent for (b)(4), lacked a lot number and expiration date and was stored with product in the released section of the warehouse.
8. Failure to establish and maintain procedures for identifying product during all stages of receipt, production, distribution and installation to prevent mix-ups, as required by 21 CFR 820.60.
a) 23 rolls of plastic in cellophane wrapping on wooden pallets in the release section of the warehouse had no identification labels, release or in-process labels.
b) During walk through of the warehouse facility on 03/24/10, multiple brands of analyzers in cartons were co-mingled with products on a shelf or in a locked cage area without any identification status on the pallet or carton surface.
9. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b).
For example, procedures for the acceptance or rejection of incoming product were not implemented. Specifically, Use of Statistical Acceptance sampling, Work Instruction Number: (b)(4) was not followed for inspecting Alcohol Dipstick, (b)(4) on 11/10/08. The procedure requires the sampling of (b)(4) units when the lot size is (b)(4). Only (b)(4) units were sampled and inspected for the lot size of (b)(4) received on 11/10/08.
10. Failure to establish adequate quality system procedures and instructions, as required by 21 CFR 820.20(e).
For example, the quality system procedures were not complete. They do not specify what testing equipment should be used during performance testing of a new lot.
11. Failure of management with executive responsibility to appoint and document a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for ensuring quality system requirements are effectively established, reporting on the performance to management, management review, quality planning and quality system procedures, as required by 21 CFR 820.20(b)(3).
For example, the Quality System Manager who is identified in the organizational chart as the Quality Management Representative has not been given the authority to:
a) Ensure the processes needed for the QMS are established, implemented, and maintained;
b) Report on the performance of the QMS to the President for review and as basis for improvement of the QMS and;
c) Ensure the promotion of awareness of regulatory requirements and meeting customer requirements through the company.
Our inspection also revealed that the Teco Diagnostic TC-101 urine analyzer, (b)(4) urine analyzer, Alcohol Saliva Dipstick and Rapid Plasma Reagin (RPR) Kitare adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency, 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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 violations, 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.
Your response should be sent to:
Blake Bevill, Compliance Director
U.S. Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact: Marco Esteves, Compliance Officer at 949-608-4439 or fax 949-608-4415.
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.
Alonza E. Cruse
Los Angeles District
Cc: Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413