Inspections, Compliance, Enforcement, and Criminal Investigations
Quantum Skincare, Inc. 31-Oct-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|New Orleans District |
297 Plus Park Blvd
Nashville, TN 37217
Telephone : 615-695-4654
Facsimile : 615-695-4683
October 31, 2005
WARNING LETTER NO. 2006 NOL-3
Mr. Jack W. Cobb, President
Quantum Skincare, Inc.
2514 Military Road
Ringgold, Louisiana 71068
Dear Mr. Cobb:
On May 31 and June 6, 2005, a U.S. Food and Drug Administration (FDA) investigator inspected your medical device manufacturing facility, located at 2514 Mill Street, Ringgold, Louisiana. This inspection determined your firm manufactures infrared lamps which are medical devices within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC), Section 321(h)]. These Class II medical devices are not exempt from the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, as specified in Title 21, Code of Federal Regulations, Part 820 (21 CFR 820) . You can find the Act and the CFR through links in FDA's Internet home page at http://www.fda.gov.
Our inspection determined your devices are adulterated within the meaning of Section 501(h) of the Act [21 USC, Section 351(h)], as the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformance with the CGMP requirements of the QS regulation, as specified in 21 CFR 820. Specific violations follow :
1. Failure of management with executive responsibility to ensure an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 CFR 820 .20. Specifically, your firm does not maintain written procedures for corrective and preventive actions, complaint handling, design controls, and internal audits. Also, your firm does not maintain a complaint file, assembly device history records, design history file for the Quantum Quasar Plus device, and does not document in-process test results. In addition, your firm has not recorded and investigated complaints and validated the shipping process.
2. Failure to establish procedures to control the design process, as required by 21 CFR 820.30(a) . Specifically, your firm does not have written procedures for design control for your Quantum Quasar Plus Infrared Lamp device.
3. Failure to establish or maintain a design history file, as required by 21 CFR 820.30(j). Specifically, your firm does not have a Design History File for your Quantum Quasar Plus Infrared Lamp device to show the activities conducted during its design control process.
4. Failure to establish procedures for implementing corrective and preventive actions, as required in 21 CFR 820.100(a). Specifically, your firm does not have written procedures for corrective and preventive actions.
5. Failure to establish complaint handling procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). Specifically, your firm does not have complaint handling procedure(s).
6. Failure to maintain a complaint file, as required by 21 CFR 820.198(a) . Specifically, your firm has not recorded, as consumer complaints, reported failures of broken power cords for the Quantum Quasar Plus Infrared Lamp device.
7. Failure to investigate complaints involving the possible failures of a device to meet any of its specifications, as required by 21 CFR 820.198(c). Specifically, your firm has not investigated reported failures involving power cord breakage of the Quantum Quasar Plus Infrared Lamp device.
8 . Failure to document acceptance test results of in-process product, as required by 21 CFR 820.80(c). Specifically, your firm does not document in-process test results, nor document whether the component/subassembly passed or failed in-process testing during the assembly of your Quantum Quasar Plus Infrared Lamp device.
9. Failure to establish procedures for changes to specifications, procedures, and processes, as required by 21 CFR 820.70(b). Specifically, your firm does not have written change control procedures for making changes to specifications, procedures, and processes.
10. Failure to validate and approve by established procedures, a process whereby the results cannot be fully verified by subsequent inspection and testing, as required by 21 CFR 820.75(a). Specifically, your firm has not validated the shipping packaging process for the Quantum Quasar Plus Infrared Lamp device.
11. Failure to have a device history record that demonstrates the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184. Specifically, your firm has no device history records for the assembly of the Quantum Quasar Plus Infrared Lamp device.
12. Failure to document training, as specified by 21 CFR 820.25(b). Specifically, your firm has no documentation showing device assemblers have been trained in their operation.
13. Failure to establish procedures for internal quality audits and conduct such audits, as required by 21 CFR 820.22. Specifically, your firm has not established a written procedure for conducting internal quality audits, nor has it conducted internal audits of the quality system.
14. Failure to establish policy and objectives for quality, as required by 21 CFR 820.20(a). Specifically, your firm has not written a quality policy and quality objectives.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA 483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.
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, no pre-market submissions for Class III devices to which the QS/CGMP deficiencies are reasonably related will be cleared or approved until the violations have been corrected . Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. We recognize at the close of the inspection you made a verbal commitment to correct the observed deficiencies . However, you should notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure similar violations will not recur. You should include in your response copies of documentation such as written procedures for corrective and preventive actions, complaint handling, design controls, and internal audits, and copies of other documents which may assist us in evaluating your response. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
Your reply should be directed to the U.S. Food and Drug Administration, Attention: Nicole F. Hardin, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Ms. Hardin at (615) 695-4654.
H. Tyler Thornburg
New Orleans District