Progressive Medical Inc 1/10/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
11630 West 80th Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100
January 10, 2012
RETURN RECEIPT REQUESTED
Ref. KAN 2012-05
Mr. Mark M. Martin
Progressive Medical, Inc.
11085 Gravois Industrial Court
Saint Louis, Missouri 63128
Dear Mr. Martin:
During an inspection of your firm located in Saint Louis, Missouri on August 30, 2011 through September 01, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the MedPro AccuFlo Elastomeric Infusion Pump, Progressive Medical Disposable Uterine Manipulator, Progressive Medical HSG-SONO Catheter, PMI Puncture Closure Device, PMI’s Disposable Cholangiography Catheters, PMI IV Start Kits, Laceration Trays, Progressive Medical Huber Needle Infusion Set, PTFE Coated Laparoscopic, and Arthroscopic Electrodes. 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 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 establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example, your firm does not have any procedures for Corrective and Preventive Actions.
2. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b). For example, for your firm’s labeled products, the contract manufacturers of these products do not have the design plans that represent your firm’s review and approval of the following designs:
- Progressive Medical Disposable Uterine Manipulator,
- Progressive Medical HSG-SONO Catheter,
- Progressive Medical, Inc. (PMI) Puncture Closure Device,
- PMI’s Disposable Cholangiography Catheters,
- PMI IV Start Kits and Laceration Trays,
- Progressive Medical Huber Needle Infusion Set, and
- PTFE Coated Laparoscopic and Arthroscopic Electrodes.
3. Failure to define the type and extent of control to be exercised over the product, services, suppliers, contractors and consultants, based on the evaluation results, as required by 21 CFR 820.50(a)(2). For example:
- Your firm does not have a procedure for qualifying contractors to manufacture PMI products.
- Your firm does not have any documentation for the evaluation of manufacturers that supply your firm with medical devices.
- Your firm does not document approval of contract manufacturers. Specifically, your firm did not ensure that Medpro International obtained premarket clearance for the AccuFlo and AccuRx infusion pumps.
4. Failure to establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40. For example, your firm has no procedures that control required documents and changes to these documents. In addition, the following procedures do not contain the document approval date and/or the signature of the approving official:
- Medical Products Distributorship Policies and Procedures,
- PMI Product Incident- Procedure Policy,
- Return Goods Policy, and
- Progressive Medical Inc. Internal Audit Process.
5. Failure of management to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR 820 and the manufacturer’s established quality policy and objectives, as required by 21 CFR 820.20(c). For example, your firm does not have an established management review procedure.
Our inspection also revealed that your firm’s MedPro AccuFlo Elastomeric Infusion Pump, Progressive Medical Disposable Ulterine Manipulator, Progressive Medical HSG-SONO Catheter, PMI Puncture Closure Device, PMI’s Disposable Cholangiography Catheters, PMI IV Start Kits, Laceration Trays, Progressive Medical Huber Needle Infusion Set, PTFE Coated Laparoscopic, and Arthroscopic Electrodes devices are misbranded under Section 502(t)(2) of the Act, [21 U.S.C. § 352(t)(2)], in that 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 U.S.C. § 360i], 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 Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm does not have an MDR procedure to indicate when a reportable event should be reported to FDA.
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. In addition, 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.
Please send your response to Danial S. Hutchison, Compliance Officer, at the above address. If you have any questions concerning the content of this letter, please contact Mr. Hutchison.
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.
John W. Thorsky
Director, Kansas City District