Inspections, Compliance, Enforcement, and Criminal Investigations

China Daheng Group Inc. 1/15/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

 WARNING LETTER
JAN 15, 2014
 
VIA UNITED PARCEL SERVICE
 
Xiaohong Yang
General Manager
China Daheng Group, Inc.
#A9 Shangdi Xinxilu, Haidian District
Beijing, 100085, China
 
Dear Ms. Yang:
 
During an inspection of your firm located in Beijing, China,on July 15, 2013, through July 19, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical powered laser instruments.  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 to affect the structure or function of the body.
 
These devices include the Denlase and Penlase lasers, which are electronic productssubject to compliance with Subchapter C of the Act, Electronic Product Radiation Control, the requirements at 21 CFR 1000-1005, and the performance standards at 21 CFR 1010, 1040.10, and 1040.11
 
At the conclusion of the inspection, a Form FDA 483 (FDA 483) List of Inspectional Observations, was issued due to deficiencies with the performance standards at 21 CFR 1010, 1040.10, and 1040.11, and with your firm’s quality system pertaining to the Quality System (QS) regulation, 21 CFR 820.  We received a response from Siyi Yao, Chief Engineer and Management Representative, dated August 5, 2013, concerning our investigator’s observations noted on the FDA 483 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 provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers.
 
Your firm’s response, dated August 5, 2013, is not adequate because the revised user manual was not submitted with the letter.
 
2.    Failure to attach a certification statement on the product, as required by 21 CFR 1010.2.  For example, the manufacturer’s identification label shown in the Denlase Operator’s Manual, the quality documents provided by the manufacturer during the inspection and the Denlase product report, accession number (b)(4), dated July 16, 2010, and the Penlase product report, accession number (b)(4) dated July 29, 2011, lack a copy of the required certification statement.
 
Your firm’s response, dated August 5, 2013, is not adequate because lack of certification was not addressed.
 
3.    Failure to submit annual reports, as required by 21 CFR 1002.13.  For example, the CDRH database showed no annual report submitted by September 1, 2012, which shall cover the 12-month period ending on June 30th preceding the due date of the report. Specifically, your firm did not submit an annual report for the period of July 1, 2011, to June 30, 2012.
 
Your firm’s response, dated August 5, 2013, is not adequate. Your firm did not submit an annual report for the reporting period of July 1, 2011, to June 30, 2012. Rather, it submitted an annual report for the reporting period of July 1, 2012 to June 30, 2013, which was due by September 1, 2013, dated September 9, 2013, accession number (b)(4)
 
4.    Failure to provide a listing of all controls, adjustments, and procedures for operation and maintenance, including the “Caution – use of controls or procedures . . . .” in the user information, as required by 21 CFR 1040.10(h)(1)(iv). For example, your firm’s Denlase user manual does not contain the required warning.
 
Your firm’s response, dated August 5, 2013, is not adequate because the revised user manual was not submitted with the letter.
 
5.    Failure to include a reproduction of the warning logotype label on sales brochures, as required by 21 CFR 1040.10(h)(2)(i).  For example, the descriptive brochure for the Denlase and Penlase products lack the warning logotype label.
 
Your firm’s response, dated August 5, 2013, is not adequate because the revised sales brochure was not submitted with the letter.
 
These violations are prohibited acts under section 538(a)(4) of the Act, 21 U.S.C. § 360oo(a)(4), which prohibits any manufacturer from failing or refusing to submit reports required pursuant to section 537(b) of the Act.  Violations of section 538 are grounds for enforcement action under section 539 of the Act. 
 
Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents related to laser products are available on FDA's web site at: http://www.fda.gov/RadiationEmittingProducts/RadiationEmittingProductsandProceures/HomeBusinessandEntertainment/LaserProductsandlnstruments/default.htm.
 
In reference to items 1 to 5 relating to Electronic Product regulations, your firm is required, under 21 CFR 1003.11(b), to immediately provide a written response to FDA with the number of referenced products that have been produced and the number of those products that have left the place of manufacture. In addition, if the product distribution was confined to specific geographical areas of the United States, please specify those areas. We request that you provide the response no later than 15 days after receipt of this letter including supporting evidence and documentation pursuant to one of the options listed below:
 
1.    Refutation – Under 21 CFR 1003.11(a)(3), your firm may submit its views and evidence to establish that the alleged failures to comply do not exist.
 
2.    Exemption Request – Under 21 CFR 1003.30(a), your firm may request an exemption from user and dealer/distributor notification requirements under 21 CFR 1003.10(b). Your firm must respond within 15 days from receipt of this letter to apply for such an exemption. If exempted from such notification, your firm is not required to correct the violative products (under 21 CFR 1004.1(a)). Your firm’s request must include the grounds upon which such exemption is requested (see 21 CFR 1003.30 and 1003.31) and the information required under 21 CFR 1003.20.
 
3.    Purchaser Notification and Corrective Action – If your firm neither refutes the noncompliance nor requests an exemption, then it must: (a) notify purchasers and dealers/distributors of the violative products as specified in 21 CFR 1003.10(b), and (b) submit a written corrective action plan (CAP) for approval showing how your firm will fulfill its obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of the violative products.
 
a)    Notification Letter – Requirements for preparation of notification letters are prescribed in 21 CFR 1003.21 and 1003.22. A copy of the notification letters sent to purchasers and dealers must also be sent to the FDA. It is recommended that your firm submit a draft of this letter to us for review.
 
b)    Corrective Action Plan (CAP) – Instructions for preparation of a CAP may be found in 21 CFR 1004.2, 1004.3, or 1004.4. Such a plan must expeditiously correct the non-compliances and must be approved as set out in 21 CFR 1004.6. 
 
If your firm requests additional time to prepare its refutation, exemption request, notification letter, or CAP, it must provide the reasons for any delays and a reasonable target date for the full submission of its response. Be aware that if an acceptable CAP cannot be prepared promptly, your firm may be required to proceed with interim notification to affected persons as required by 21 CFR 1003.11(c) and 1003.21. Therefore, your firm is encouraged to immediately begin its preparation of accurate user location lists.
 
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 violations are reasonably related will not be approved until the violations 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, as well as 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 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 these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed.  Your firm’s response should be comprehensive and address all violations included in this letter. Please provide a translation of documentation not in English to facilitate our review.
   
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act,21 U.S.C. § 351(h), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820.  These nonconformities include, but are not limited to, the following:
 
Failure to establish and maintain calibration procedures that include specific directions and limits for accuracy and precision, as required by 21 CFR 820.72(b).
 
For example, your firm’s procedure (b)(4), “Control Procedure for Inspection and Measuring Equipment,” requires measuring equipment to meet its intended use and limits; however, the calibration record of the (b)(4), used to measure the output power of the (b)(4), is not calibrated for its range of intended use. The (b)(4) is less than (b)(4). and the lowest calibration point is (b)(4).
 
The adequacy of your firm’s response cannot be determined at this time. Your firm states that the (b)(4) was recalibrated immediately after the inspection, and it was found to be calibrated correctly within the required (b)(4) and (b)(4). Your firm states that it will revise its calibration procedure and provide a copy of the calibration certificate. Your firm provided its corrective action plan, but no evidence of the corrective actions has been provided. Therefore, CDRH cannot determine the adequacy of your firm’s response.
 
1.    Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of 21 CFR 820, as required by 21 CFR 820.184.
 
For example, the DHR for each laser system produced does not include a copy the primary identification label showing the serial number of each system.  There is no procedural requirement that the DHR shall include, or refer to the location of, the required labeling. 
 
We have reviewed your response and determined that it is inadequate.  Your firm’s response describes plans to include a copy of the primary identification label showing serial numbers of each device in its device history record. Your firm states that it will revise its “Device History Records Form” (b)(4) to add space on the form to include a copy of the label, revise its label procedure, and train its employees to use the revised procedures. There is no indication that your firm will perform retrospective review of the previous DHRs and correct similar deficiencies. 
 
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CMS case # 411469 when replying. If you have any questions about the contents of this letter, please contact: LaShanda Long at 301-796-5770 (phone) or (301) 847-8137 (fax).
 
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. 
 
Sincerely yours,
/S/                                                                                   
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
     Radiological Health
 
 
cc:
 
U.S. Agent
David Boegler
DC International, LLC
624 Cypress Green Cir
Wellington, FL 33414
Phone: 561 337-8888
Fax: 5618990467
Email: David@Dcinter.com
         

Page Last Updated: 09/11/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English