Shippert Medical Technologies 4/25/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
April 25, 2013
Ref: DEN-13-13 WL
VIA UPS Over Night
Ronald D. Shippert, MD
Chief Executive Officer and Co-Owner
Ms. Sara L. Shippert
President and Co-Owner
Shippert Medical Technologies
6248 S. Troy Circle, Suite A
Centennial, CO 80111-6485
Dear Mr. and Ms. Shippert:
During an inspection of your firm located at 6248 S. Troy Circle, Suite A, Centennial, Colorado, on January 9-11, 14-16, 23, and 28, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Lipoplasty Suction System units. 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 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. You can find these regulations on the FDA website at www.fda.gov
Significant deviations include, but are not limited to, the following:
- You failed to adequately validate the results of a process when the process could not be fully verified by subsequent inspection and test as required by 21 CFR 820.75(a). Specifically, your firm could not provide documentation of validation for:
- The sterilization process of the Tissu-Trans Filtron products.
- The injection molding process for the Tissu-Trans Filtron canisters.
The Tissu-Trans Filtron has different volume canisters and a mesh lining to collect fat, so the design of the product is different than the TT-10 and TT-60 that was validated in 2006. In addition, the injection molding process is performed by a contract manufacturer; however, your firm is required to validate these two processes in order to be in compliance with the medical device regulations.
- You failed to adequately document the results of the design validation, including method(s), the date, and the individual(s) performing validation in the design history file. Specifically, your firm did not establish a validation protocol that defined operating conditions and methods to ensure that design validation of the Tissu-Trans Filtron products conformed to user needs and intended uses as required by 21 CFR 820.30(g).
Furthermore, you state that the Tissu-Trans Filtron System is so similar to the TT-10 and TT-60 that you did not deem it necessary to go through the entire design validation and verification testing for the Tissu-Trans Filtron System; however, you did obtain a new 510(k) approval for this product.
- You failed to confirm by design verification that the design output meets the design input requirements as required by 21 CFR 820.30(f). Specifically, your firm could not provide design documentation to confirm that design outputs met the design inputs for the Tissu-Trans Filtron products.
In addition, your firm’s Project Plan document, “DESIGN VERIFICATION”, only stipulated that product samples will be fabricated for (b)(4) as the following action for design verification.
- You failed to have a complete risk analysis for the Tissu-Trans Filtron products as required by 21 CFR 820.30(g). Specifically, your checklist for the application of risk management and the introduction to risk analysis did not evaluate the risks associated with the following reported failure modes: leaking canisters, cracked lids or foreign debris within the Tissu-Trans Filtron canisters.
Although you received complaints for leaking canisters, cracked lids, and foreign debris, the applications of risk management checklist approved on 7/23/2009 does not indicate that your firm evaluated leaks, cracks, and foreign debris as potential hazards.
- You failed to adequately establish procedures for corrective and preventive actions as required by 21 CFR 820.100(a). Specifically, your procedure for corrective and preventive actions state that the Chief Financial Officer will assign personnel independent of the corrective/preventive action to audit the action for effectiveness. However, (b)(4) closed corrective/preventive action records did not have documentation as verified before closure.
- You failed to adequately define the type and extent of control to be exercised over the product and suppliers. Specifically, your subcontractor evaluation form completed for your Tissu-Trans Filtron canister supplier in 2009 did not define the type and extent of the control to be exercised over your product as required by 21 CFR 820.50(a)(2).
Your procedure states that (b)(4) subcontractor will complete an evaluation form and a non-disclosure form either by mail, personal visit, or by phone. The form completed in 2009 for your subcontractor of the Tissu-Trans Filtron canister did not contain any language regarding process validation or inspectional requirements for products being supplied. Furthermore, your management did not know whether the injection molding process, used to produce the Tissu-Trans Filtron product canisters and lids, had been validated. Your Management contacted the supplier but was unable to confirm that the process had been validated.
- You failed to adequately establish procedures for acceptance activities as required by 21 CFR 820.80(a). Specifically, your firm has neither defined acceptance criteria for raw materials nor evaluated raw materials upon receipt. Your documentation of incoming material acceptance only consists of verification of identity of product and quantity received. There are no criteria for final acceptance of product. In addition, management stated that the product is simple so no criteria have been established.
- You failed to adequately maintain the device master record (DMR) as required by 21 CFR 820.181. Your firm’s DMR does not include quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used.
- You failed to adequately establish procedures for design review as required by 21 CFR 820.30(e). Specifically, your firm’s design review procedures do not ensure final design review is completed before marketing the product. The Tissu-Trans Filtron products were sold beginning in February 2010. However, the final design review was not completed until two months later on April 23, 2010, and the design validation review was not completed until seventeen months later on July 6, 2011.
We acknowledge receipt of your February 13, 2013 letter responding to our Inspectional Observations, Form FDA 483 dated January 28, 2013. Your response is inadequate in that although you reported making corrections in some areas where deficiencies were noted, you did not provide any documentation of these corrective actions. Your corrective actions will be fully evaluated during our next inspection.
You 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 Food and Drug Administration 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 that they may take this information into account when considering the award of contracts.
Additionally, premarket approval applications for 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 (15) working days from the date you receive this letter of any additional steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your 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.
Finally, you should know that 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 Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Your response should be sent to: Food and Drug Administration, Denver District, P. O. Box 25087, (6th Ave. and Kipling Street, DFC, Bldg 20), Denver, CO 80225-0087, Attention: Carolyn A. Pinney, Compliance Officer. If you have any questions, please contact Mrs. Pinney at (303) 236-3024.
LaTonya M. Mitchell
Denver District Director