Inspections, Compliance, Enforcement, and Criminal Investigations
Prime Herbs Corporation 12/10/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
VIA UNITED PARCEL SERVICE
December 10, 2012
Dr. Genevieve I. Hsia
Prime Herbs Corporation
1872 Hartog Drive
San Jose, California 95131
Dear Dr. Hsia:
During an inspection of your firm located in San Jose, California, from August 7 through August 14, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm imports and distributes the Precision TDP Floor Lamp (Infrared Heating Lamp). 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 to affect the structure or any function of the body.
This inspection revealed that the Precision TDP Floor Lamp is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h); misbranded within the meaning of section 502(t) of the Act, U.S.C. § 352(t); adulterated within the meaning of section 501(f)(1)(B) of the Act, 21 U.S.C. § 352(f)(1)(B); misbranded within the meaning of section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1) and misbranded within the meaning of section 502(o) of the Act, U.S.C. § 352(o). We note your firm has not responded to the Form FDA 483 (FDA 483).
This inspection revealed that the Precision TDP Floor Lamp 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, 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.
These violations include, but are not limited to, the following:
1. Failure to have personnel with the necessary training and experience to perform their jobs, as required by 21 CFR 820.25(a). Specifically, you and your manager who are responsible to ensure compliance with the Quality System regulation have not been trained to perform design controls, complaint handling, and/or corrective and preventative actions.
2. Failure to establish procedures for quality audits, as required by 21 CFR 820.22. During our inspection both you and your manager stated that you did not have procedures related to quality auditing, you explained that you review the accuracy of the receipt and fulfilling of orders, however do not conduct any quality system audits.
3. Failure to establish procedures for design control, as required by 21 CFR 820.30(a). During our inspection you stated that you have not developed any specifications, requirements, or other design criteria for the Precision TDP Lamp. You further stated that you adopted the manufacturer’s specifications for an off-the-shelf lamp product, but do not have any records documenting your review and approval that these specifications meet the requirements or address the intended use of your device.
4. Failure to establish procedures for corrective and preventative action, as required by 21 CFR 820.100(a). During our inspection you stated that you do not have and are unfamiliar with the terms, corrective and preventative actions.
5. Failure to establish procedures to control labeling activities, as required by 21 CFR 820.120. During our inspection you told our investigator that you do not have any procedures covering the relabeling operations of the Precision TDP Lamps with the Prime Herbs brand name, or for the inclusion of instructions for use.
6. Failure to ensure device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution, as required by 21 CFR 820.130. During our inspection you told our investigator that you have received complaints from customers about your Precision TDP Lamp not functioning as it may have been damaged during shipping; however, you do not have procedures or documentation regarding any packaging validation to ensure the Precision TDP Lamp is not damaged during handling and distribution.
7. Failure to establish procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. During our inspection you stated that you do not have procedures or methods, written or otherwise, to evaluate the adequacy of your suppliers. You also stated that you do not have any written contracts or agreements with your supplier for any manufacturing operation of this device and that you do not know the production site of the device which you import and distribute under your 510(k) clearance, with labeling declaring Prime Herb Corporation as the manufacturer.
8. Failure to establish procedures for acceptance activities, as required by 21 CFR 820.80(a). During our inspection, you stated that you do not have any procedures for accepting or rejecting the Precision TDP Lamp based on specified requirements. Furthermore, you do not require a certificate of conformance, certificate of analysis, or any form of certification that the TDP Lamps you receive and distribute conform to specifications and quality criteria necessary to perform as intended.
9. Failure to establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). During our inspection you stated that you do not have procedures for handling product that does not meet specifications; you do not have any written specifications. You also do not have procedures for returning defective products back to your supplier.
10. Failure to establish document control procedures, as required per 21 CFR 820.40. During our inspection you stated that you do not have any procedures to track or control versions of the instruction for use for the Precision TDP Lamp. You further stated that you have made changes previously to the instructions for use, but do not have any revision identification or other document control to ensure the latest version is being used.
11. Failure to establish a device master record, including or referring to the location of your device specifications, production process, quality assurance, and packaging/labeling for each model of the Precision TDP Lamp, as required by 21 CFR 820.181. During our inspection you stated that you do not have any records relating to any aspect of the manufacturing of the Precision TDP Lamp. You again stated that you adopted the manufacturer’s specifications but have no records of this review and approval, and have admitted to not knowing what firm manufactures the device you import and distribute.
12. Failure to establish a designated unit for receiving, reviewing and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). During our inspection you stated that you do not have any procedures for reviewing and evaluating complaints. You stated that you have received complaints regarding defects such as the lamp not turning on or not heating correctly. You stated that if you receive a quality complaint, you forward the message to your supplier in China.
13. Failure to establish procedures for control and distribution of finished devices, as required per 21 CFR 820.160(e). During our inspection, you explained that your firm does not inspect the Precision TDP Lamp to ensure they meet performance specifications or have not been damaged in transit. You also stated that you do not have procedures to ensure only accepted units of TDP Lamps are distributed.
14. Failure to establish procedures for device history records, as required per 21 CFR 820.184. During our inspection, you stated that you were unfamiliar with the term device history record, and have never seen, requested, or generated device history records or any manufacturing records for your Precision TDP Lamp.
Our inspection revealed that your firm’s Precision TDP Infrared Heating Lamps are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed to establish Medical Device Reporting procedures as required by 21 CFR 803.17. During our inspection, you stated that you were unfamiliar with the terms MDR, medical device report, adverse event, or reportable event.
Our inspection also revealed that your firm is promoting and marketing the Precision TDP Floor Lamp in the United States without the required marketing clearance or approval, in violation of the Act. When there are significant changes to the intended use of a cleared device, a new application must be submitted under section 510(k) of the Act, 21 U.S.C. § 360(k), and cleared prior to marketing. See 21 CFR 807.81(a)(3).
Your firm obtained clearance for over-the-counter use of the Precision TDP Lamp (K081720) under section 510(k) with the following indications:
“. . .may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may help muscle spasms, minor sprains and strains, and minor muscular back pain.”
FDA reviewed your website, www.primeherbs.com, and found that your firm is making claims for this device that represent major changes or modifications to the intended use. For example the product description refers to the device as being, “an efficient therapeutic and strengthening device,” and states: “particularly helpful in promoting microcirculation, relieving pain, and strengthening immune system.”
As a result of these changes to the intended use, the Precision TDP Lamp is adulterated within the meaning of 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 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 Precision TDP Lamp is also misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify FDA of its intent to introduce the device with new intended uses into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k), and as described under 21 CFR 807.81(a)(3)(ii).
For a device requiring premarket approval before marketing, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a premarket approval application (PMA) is pending before the agency, per 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/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
In addition, during the course of the inspection, you indicated that the User Manual for your over-the-counter device is not shipped with the product unless a specific request is made by the purchaser. Therefore, the Precision TDP Lamp is also misbranded within the meaning of section 502(f)(1) of the Act, 21 U.S.C. §352(f)(1), for failing to provide adequate directions for use.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, 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 violations 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, 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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Lawton W. Lum, Director of Compliance. Refer to the Unique Identification Number (364045) when replying. If you have any questions about the contents of this letter, please contact: Aleta T. Flores at (510) 337-6821 or fax (510) 337-6703.
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.
Barbara J. Cassens