Inspections, Compliance, Enforcement, and Criminal Investigations
Chiu Technical Corp. 24-Sep-07
Department of Health and Human Services
Public Health Service
New York District
September 24, 2007
RETURN RECEIPT REQUESTED
Eva Chiu, President
Chiu Technical Corp.
252 Indian Head Rd .
Kings Park, New York 11754-4804
Ref. No.: NYK 2007-20
Dear Ms. Chiu:
During an inspection of your firm located in Kings Park, New York between April 19, and May 1, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Transilluminator, Model BFO-150. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
This inspection revealed that this device is 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 its manufacturing, 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 (CFR), Part 820. We received a response from you, dated May 2, 2007, concerning our investigator's observation noted on the Form FDA 483, List of Inspectional Observations, which was issued to you. These violations include, but are not limited to, the following:
1. Failure to establish and maintain the Quality System procedures and instructions, as required by 21 CFR 820.20(e). For example, your firm has not established and maintained quality system procedures for the following activities:
a. Complaint Handling, as required by 21 C.F.R. 820.198(a).
b. Corrective and Preventive Action (CAPA), as required by 21 C.F.R. 820.100(a).
c. Non-Conforming Products, as required by 21 CFR 820.90.
d. Purchasing Controls, as required by 21 C.F.R. 820.50.
e. Acceptance Activities, as required by 21 CFR 820 .80(a).
f. Device Labeling, as required by 21 CFR 820.120.
2. Failure to establish and maintain procedures for management review, as required by 21 CFR 820.20(c). For example, your firm has not established and maintained procedures for management review to ensure that the quality system is maintained.
3. Failure to establish procedures for quality audits and to conduct such audits, as required by 21 CFR 820.22 . For example, there are no reports showing that your firm conducted internal quality system audits.
4. Failure to maintain device master records that include, or refer to the location of, device specifications including appropriate drawing, composition, formulation, component specifications and software specifications, as required by 21 CFR 820.181(a). For example, your firm does not have a Device Master Record for the Transilluminator, Model BFO-150 that contains or identifies the location of the device and component specifications, and other required information for the manufacturing processes.
5. Failure to establish and maintain device history records, as required by 21 CFR 820.184. For example, your firm has not established or maintained the required device history record for the Transilluminator Model BFO-150, manufactured at this facility.
Our inspection also revealed that the Transilluminator Model BFO-150 is 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:
1 Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm has not developed, maintained, and implemented written MDR procedures for internal systems that provide for timely and effective evaluation of events that may be subject to MDR requirements; a standardized review process or procedure for determining when an event meets the criteria for reporting; and timely transmission of complete medical device reports to FDA.
2. Failure to report to FDA no later than 30 calendar days of receiving information or otherwise becoming aware of information, from any source, that reasonably suggests that a device that you market: (1) may have caused or contributed to a death or serious injury; (2) has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803 .50(a)(1). For example, MedWatch Report #0933000000-2007-8002 (event date January 29, 2005), was reported to FDA on April 12, 2007, by the Risk Manager of [redacted] in Washington, D.C. Our inspection revealed that you were first made aware of this event on December 29, 2006, by an attorney representing the patient. To date, you have not submitted a MDR report for this event.
3. Failure to conduct an investigation of each MDR event and evaluate the cause of the event, as required by 21 CFR 803.50(3). For example, it was determined during the inspection that an investigation of the event that occurred on January 29, 2005, has not been conducted.
We have reviewed your response dated May 2, 2007, and have concluded that it is inadequate because the decision to discontinue the manufacture of the Transilluminator Model BFO-1 50 in 2007 does not provide an acceptable explanation of why you did not report the MDR event to FDA as required. In addition, as described above, you are responsible for conducting an investigation of each event, evaluating the cause of the event, and documenting your rationale for not reporting the event.
Our inspection also revealed that the Transilluminator Model BFO-150, is 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. § 360(g). The device is also misbranded under section 502(o) of 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). The notification required by section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency. 21 CFR 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.
The Transilluminator, Model BFO-150, is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. 360, and was not included in a list required by section 510(j) of the Act, 21 U.S.C. 360(j).
FDA has conducted a Health Risk Assessment to determine the level of risk involved when the device (fiber optic light source) is used on neonatal patients to locate a vein for intravenous infusion. FDA has determined that the hazards associated with the use of the device may cause serious injury including burns and blisters which may result in permanent, irreversible scarring, or in more extreme cases, infection and circulatory compromise. Based on this assessment, and the fact that the Model BFO-150 Transilluminator has not been approved or cleared for marketing, FDA is requesting that you voluntarily take the appropriate action to remove the [redacted] known units manufactured since 2004, and any other units that may currently be on the market. If you elect not to take voluntary action to remove all of the units, FDA may consider taking regulatory action.
You should take prompt action to correct these 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 penalties. Also, other 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 informed about the warning letters we issue, such as this one, so that they may consider this information when awarding government 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. Request for Certificates to Foreign Governments will not be granted until the violations related to the subject device have been corrected.
Please notify this office in writing, within 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 timeframe 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 Richard T. Trainor, Compliance Officer, U.S. Food and Drug Administration, 300 Hamilton Ave., White Plains, New York 10601. If you have any questions about the content of this letter please contact Mr. Trainor at (914) 682-6166, extension 34, or by FAX at (914) 682-6170.
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, 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.
Otto D. Vitillo
New York District