Shanghai Apolo Medical Technology Co., Ltd 2/23/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
FEB 23 2012
VIA UNITED PARCEL SERVICE
Shanghai Apolo Medical Technology Co., LTD
3/F, Building A, No 388
Yindu Road, Xuhui District
Shanghai 200231, China
Dear Mr. Chiu:
During an inspection of your firm located in Shanghai, China, on September 5, 2011, through September 8, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Intense Pulsed Light (IPL) Systems (broadband light source wavelength 420-1200 nanometers) and accessories used for dermatologic conditions. 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 they 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received your response dated September 16, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. 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 establish and maintain adequate procedures for validating the device design, as required by 21 CFR 820.30(g). For example, upon request by the investigator, no documentation was provided to demonstrate that the display module and controller software used in the IPL Systems and accessories was validated to ensure that it conformed to defined user needs and intended uses.
We reviewed your response and conclude that it is not adequate. You did not provide data to demonstrate that the IPL System’s software has been adequately validated. In addition, your response does not identify objective steps taken to address IPL Systems manufactured with software that was not properly validated.
2. Failure to establish and maintain adequate procedures for the identification, documentation, validation, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, upon request by the investigator, no objective evidence was provided to verify that IPL Systems and accessories design changes (IPL-HS-300 chassis) made on April 16, 2008, were documented.
We reviewed your response and conclude that it is not adequate. Your response does not include evidence that these design changes were documented. Also, the response does not address steps taken to ensure that employees are properly trained to facilitate implementation of adequate design change procedures.
3. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, Complaint Procedure QP8201, version A/1, effective September 28, 2008, is inadequate because of the following:
A. The complaint procedure failed to include an assessment to determine whether the complaint represents an event that is required to be reported to the FDA under part 820.198(a).
B. The complaint procedure failed to define a complaint as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device after release for distribution.
C. The complaint procedure failed to define a communication concerning a problem or deficiency, or concerning the quality, durability, reliability, safety, effectiveness, or performance of a device that is under warranty as a complaint.
D. The complaint procedure/form failed to require that, when an investigation is made, the record include the device name and model, device identification (serial number), and address of the complainant.
We reviewed your response and conclude that it is not adequate. Your firm did not provide evidence to demonstrate that it has an adequate complaint handling system in place. In addition, the response does not address correction or review of pre-existing complaints.
4. Failure to establish and maintain 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, (b)(4) (WI 6402 Version A/0 dated March 19, 2011) requires (b)(4).
We reviewed your response and conclude that it is not adequate. The training form for the new (b)(4) procedure does not appear to provide adequate guidance for your firm’s engineering technicians. Also, the response does not outline steps taken to address pre-existing products manufactured without adequate environmental controls and to ensure that production employees are adequately trained and adhering to the new (b)(4) procedure.
5. Failure to adequately maintain records of complaint investigations by a formally designated unit, as required by 21 CFR 820.198(e). For example, complaint investigation records for consumer complaint 2011-01-001 and consumer complaint 2011-02-002 did not include the following information:
- Device identification and serial number
- Phone number of the complainant
- Address of the complainant
We reviewed your response and conclude that it is not adequate. Your response does not include objective evidence demonstrating that the complaint handling procedure has been updated to require that device identification and serial number, phone number of the complainant, and address of the complainant be recorded on the complaint form.
6. Failure to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184. For example:
A. The device history record for in IPL Systems and accessories, IPL-HS-350 ESN 081102, lacks the signatures of the assembly operator and Quality Assurance (QA) and Quality Control (QC) approver. Also, wavelength tests for this record have no listed acceptance values and lack a record to denote whether or not they were acceptable. Specifically:
ii. Assembly steps (b)(4) were not signed by QA/QC prior to proceeding to the next step (b)(4), as required; and
iii. Production and QA/QC testing of (b)(4) lack an acceptance range mili Volts (mV) and the test measurements do not indicate whether they were acceptable. In addition, production testing is missing the frequency measurement required by the firm’s procedure.
B. The in-process device history record for the IPL Systems and accessories, IPL-HS-620-IM SN 11070D009, observed during the (b)(4) process does not include the production operator and QA/QC signatures approving the assembly processes as required your firm’s procedure.
We reviewed your response and conclude that it is not adequate. Your response does not outline objective steps taken to address pre-existing devices currently on the market and those devices not manufactured in accordance with the device master record.
7. Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40. The date and signature of the individuals approving the document shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use, as required by 21 CFR 820.40(a). Deficiencies include:
A. Your firm’s Document Control Procedure (QP 4201 version A/2 effective July 1, 2010) requires the approvals of the management representative and general manager. However, on this document, the management representative signature was observed as (b)(4), and the general manager signature was observed as (b)(4).
B. A review of the IPL Systems and accessories manufacturing operations revealed that the production traveler that contains the specifications, assembly instructions, and standard operating procedures necessary for the production could the devices could not be located. In addition, the IPL HS-315 testing operator did not have work instructions for the testing he was performing. Even after two requests by the investigator, these documents were not provided.
C. Assembly drawings for the IPL Systems and accessories, IPL HS-300, dated August 16, 2007, were provided by R&D and Quality Assurance as part of the design output and as the current device master record. However, after your firm redesigned the IPL Systems and accessories in 2009 and 2010, the drawings were not stamped obsolete.
We reviewed your response and conclude that it is not adequate.
Your response does not address the devices manufactured using the obsolete drawings. Although your firm has provided a revised document control procedure, there is no objective evidence demonstrating the actions you are taking to address devices that were previously manufactured and either currently inventoried or distributed. In addition, there is no evidence demonstrating how your firm will ensure that employees are adequately trained to facilitate implementation of the proposed revised document control procedures.
8. Failure to identify, by suitable means, the acceptance status of product to indicate conformance with acceptance criteria, as required by 21 CFR 820.86. For example:
A. Device components not approved for release were stored on a pallet in the incoming inspection area with components approved for release and used inspection testing equipment.
B. Components approved for release were not identified with a label indicating they had passed QC testing. Specifically, the FDA investigator observed a QA inspector (b)(4).
We reviewed your response and conclude that it is not adequate. It does not address pre-existing devices that were labeled inadequately after an acceptance determination. Also, the response does not address steps taken to ensure that employees are adequately trained to facilitate implementation of the proposed revised document control procedures.
9. Failure to establish and maintain procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling, as required by 21 CFR 820.140. For example, in your incoming inspection area, (b)(4).
We reviewed your response and conclude that it is not adequate. Your response does not address steps taken to prevent future product mix-ups.
Our inspection also revealed that your IPL Systems and accessories are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its 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) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Given the serious nature of the violations of the Act, IPL Systems and accessories manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response appears to be adequate, and we may need to re-inspect your facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, U.S. federal agencies may be advised of the issuance of 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Room 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CTS case EC110353/E001 when replying. If you have any questions about the contents of this letter, please contact: LaShanda Long, Chief, General Surgery Devices Branch, Division of Enforcement A, Office of Compliance, CDRH at 301-796-5770 or fax 301-847-8137
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and