Hair Labs International, Inc. 8/9/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
August 9, 2013
WARNING LETTER NO. 2013-NOL-16
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
James H. Britt, Sr., President
Hair Labs International, Inc.
742 Harpeth Knoll Road
Nashville, Tennessee 37221-3516
Dear Mr. Britt:
On April 19, 2013, United States Food and Drug Administration (FDA) investigators inspected your firm, located at 742 Harpeth Knoll Road, Nashville, Tennessee. The inspection determined your firm is operating as a specification developer/manufacturer of a Class II medical device which is also a Class IIIa medical laser product called AlphaLase LX50. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 United States Code (USC) 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 this device is adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because 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. FDA has not received a response concerning our investigators’ observations noted on the FDA 483, Inspectional Observations, issued to you on April 19, 2013. Violations revealed during the inspection include, but are not limited to, the following:
1. 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). Such procedures shall ensure complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA, per 21 CFR 803-Medical Device Reporting (MDR). Specifically, your firm has no standard operating procedures implemented to determine if the complaint received represents an MDR reportable event. You failed to implement a standard operating procedure to ensure:
- All complaints are processed in a uniform and timely manner;
- Oral complaints are documented upon receipt; and
- Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA, as required by 21 CFR 803-MDR.
2. Failure to establish procedures for quality audits and conduct such audits to assure the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. Specifically, you do not have procedures addressing quality audits, nor do you have records documenting quality audits of your facility and suppliers.
3. Failure to implement procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm failed to define, document, and implement purchasing control procedures to ensure the AlphaLase LX50 purchased from your contract manufacturer conforms to your firm’s specified requirements.
4. Failure to establish procedures for corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm failed to establish procedures for the following requirements:
a. Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems;
b. Investigating the cause of nonconformities relating to product, processes, and the quality system;
c. Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
d. Verifying or validating the CAPA to ensure such action is effective and does not adversely affect the finished device;
e. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
f. Ensuring information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and,
g. Submitting relevant information on identified quality problems, as well as CAPAs, for management review.
5. Failure to establish and maintain adequate procedures to control the design of the device in order to ensure specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example, your firm failed to establish and maintain written procedures to control the design process, including requirements for design inputs, design outputs, design reviews, design verification/validation, design transfer and design changes for the AlphaLase LX50 device.
6. Failure to establish and maintain a Design History File (DHF) for each type of device to demonstrate the design was developed in accordance with the approved design plan and design control requirements, as required by 21 CFR 820.30(j). For example, your firm failed to establish a DHF for the AlphaLase LX50 device to demonstrate the device was developed in accordance with an approved design plan and design control requirements, pursuant to 21 CFR 820.30(j).
7. Failure to maintain Device Master Records (DMRs) for your AlphaLase LX50 software, as required by 21 CFR 820.181. For example, your firm has not documented, or referenced the location of, the following required information for the device you manufacture:
a. Device specifications;
b. Production process specifications;
c. Quality assurance procedures and specifications; and
d. Packaging and labeling specifications.
8. Failure to establish and maintain adequate procedures to ensure Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate the device is manufactured in accordance with the DMR, as required by 21 CFR 820.184. For example, your firm failed to establish written procedures for maintaining DHR’s. In addition, your firm does not maintain a complete device history which includes all acceptance/release activities and the primary identification label for your AlphaLase LX50 device.
9. Failure of management with executive responsibility to review the suitability of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of this part, as required by 21 CFR 820.20(c). For example, your firm failed to establish management review procedures and conduct management reviews as a manufacturer of a medical device.
10. Failure of management with executive responsibility to establish policy and objectives for, and commitment to, quality, as required by 21 CFR 820.20(a). Management with executive responsibility shall ensure the quality policy is understood, implemented, and maintained at all levels of the organization. For example, your firm failed to establish policy and objectives for, and commitment to, quality as a manufacturer of a medical device.
Our inspection also revealed your firm’s devices are misbranded under Section 502(t)(2) of the Act, 21 USC 352(t)(2), because 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 USC 360(i), and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. Specifically, your firm did not have any MDR procedures.
Our inspection also revealed the AlphaLase LX50 is adulterated under Section 501(f)(1)(B) of the Act, 21 USC 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 USC 360e(a), or an approved application for an investigational device exemption (IDE) under Section 520(g) of the Act, 21 USC 360j(g). The AlphaLase LX50is also misbranded under Section 502(o) the Act, 21 USC 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 USC 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 information 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 your firm submits and decide whether the product may be legally marketed.
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/or civil money penalties. Also, Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Additionally, PMA applications for Class III devices 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.
You should respond 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 your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your firm’s 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 firm’s response should be comprehensive and address all violations included in this Warning Letter.
Finally, you should know 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 FDA 483, issued at the close out of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance 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.
Your firm’s response should be sent to: Ms. Kimberly Dutzek, Compliance Officer, at the address above. If you have any questions about the content of this letter please contact Ms. Dutzek at (615) 366-7826.
Patricia K. Schafer
New Orleans District