Inspections, Compliance, Enforcement, and Criminal Investigations

Transcription

1 Inspections, Compliance, Enforcement, Criminal Investigations Crothall Healthcare, Inc. Department of Health Human Services Public Health Service Food Drug Administration New Orleans District 404 BNA Drive Building Suite 500 Nashville, TN Telephone: (615) FAX: (615) December 29, 2009 WARNING LETTER NO NOL-06 FEDERAL EXPRESS Delivery Signature Requested Robert H. Ketteh, President/CEO Crothall Healthcare, Inc. 955 Chesterbrook Boulevard Wayne, Pennsylvania Dear Mr. Ketteh: During an inspection of your facility, Steripac, located at nd Street South, Birmingham, Alabama, on July 27 through July 30, 2009, investigators from the United States Food Drug Administration (FDA) determined your firm manufactures sterile surgical linen packs. Under Section 201(h) of the Federal Food, Drug, Cosmetic Act (the Act), [21 United States Code (USC) 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 these devices are adulterated within the meaning of Section

2 501(h) of the Act [21 USC 351(h)], in 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 Part 820 (21 CFR 820). We received a response from Mr. Paul Hickey, General Manager, Crothall - Steripac, dated September 30, 2009, concerning our investigators' observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, issued to him on July 30, We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following: 1. Failure to establish maintain procedures for implementing corrective preventive action (CAPA), as required by 21 CFR (a). For example, your firm has not established or implemented written procedures for implementing CAPA. The only management official on site explained he was not aware of the requirements. We reviewed your response conclude it is inadequate because the CAPA section of the "Steripac Policy Procedures Manual", dated September 10, 2009, fails to provide the steps for verifying or validating the CAPA to ensure such action is effective does not adversely affect the finished device. Additionally, there is no approval signature for this document. 2. Failure to establish maintain procedures to control product which does not conform to specified requirements, as required by 21 CFR (a). For example, your firm failed to establish procedures for hling controlling nonconforming product. The only Management official on site explained he was not aware of the requirements. We reviewed the "Control of Non-Conforming Material" section of the "Steripac Policy Procedures Manual", included in your response, note it fails to require an evaluation of the nonconformance including a determination of the need for an investigation notification to the persons or organizations responsible for the nonconformance. Additionally, there is no evidence the "Steripac Policy Procedures Manual", has been reviewed, approved implemented. 3. Failure to establish maintain adequate procedures for receiving, "reviewing, evaluating complaints by a formally designated unit to ensure they are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting (MDR), as required by 21 CFR (a)(3). For example, your complaint hling procedures do not include a requirement that all complaints be evaluated for MDR reportability. We reviewed your response conclude it is inadequate because your complaint hling procedure has not been revised to comply with the regulation requirements. Specifically, you included a copy off , "Product Complaint Form" with your response. This form includes a space for selecting yes or no as an answer to the question of the need to generate an MDR as a result of the complaint. However, the form does not provide for documenting

3 the evaluation of the need for MDR reporting justification ofthe decision. No evidence was provided to demonstrate the corresponding "Complaint Hling" procedure was modified to include the instructions to evaluate document the need to report the complaint as an event under 21 CFR Failure to document acceptance activities, as required by 21 CFR (e). For example your firm failed to document all of the acceptance activities which are performed such as inspections, tests, other verification activities. We reviewed your response conclude it is inadequate because there is no evidence to demonstrate the inspections, tests other verification activities are being documented. You included a copy of the Section , "Device History Record", with your response. This document indicates the computerized system (b)(4) is used to maintain device history records. No evidence was provided to demonstrate such system has been validated implemented. No evidence was provided to demonstrate procedures to document acceptance activities using the computerized system have been developed implemented. 5. Failure to establish maintain procedures to ensure all purchased or otherwise received product services conform to specified requirements, as required by 21 CFR For example, your firm failed to establish purchasing control procedures to define implement adequate quality controls which must be met by suppliers contractors. The only management official on site explained he was not aware of the written purchasing control procedures were required. We reviewed your response concluded it is inadequate because no evidence was provided to demonstrate procedures have been established to ensure all purchased or otherwise received product services conform to specified requirements. You included a copy of a certificate of conformance for one material vendor; however, a copy of an approved purchasing control procedure was not provided. 6. Failure to maintain Device Master Records (DMRs) to ensure the DMR for each type of device shall include or refer to the location of production process specifications, including the appropriate equipment specifications, production methods, production procedures, production environment specifications, as required by 21 CFR (b). For example, the device master records for the Gown Pack (G-2) the Towel Pack (T-12) do not include or refer to the location of the production process specifications including the appropriate equipment specifications, production methods, production procedures for manufacturing the devices. We reviewed your response conclude it is inadequate because no evidence was

4 provided to demonstrate DMRs include or refer to the location of production process specifications including the appropriate equipment specifications, production methods, production procedures, production environment specifications. You included a copy of master file records for the G-2, Gown Pack, XXLG, T-12, Five Towel Pack, which were revised to refer to the "SOP manual" to determine the process specifications, fold/wrap methods, production procedures. However, no evidence was presented to demonstrate the referred document provides the required information as stated above. 7. Failure to establish maintain adequate procedures to control all documents, as required by 21 CFR For example, records of changes made to the manufacturing procedures were not maintained the signature of the approving individual, the approval date, when the change becomes effective were not documented, as required by 21 CFR (b). We reviewed your response conclude it is inadequate because no evidence was provided to demonstrate procedures to control documents have been established. You included a copy of the revised "STERIPAC SOP MANUAL"; however this manual does not address how documents document changes are reviewed for adequacy approved. The manual fails to address the designation of an individual to review approve such documents changes. 8. Failure of management with executive responsibility to review the suitability of the quality system at defined intervals with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of this part, as required by 21 CFR (c). For example, your firm failed to establish implement written management review procedures. The only management official on site explained he was not aware of the requirements. We have reviewed your response have concluded it is inadequate because Section 3.11, "Quality System Review" of the "Steripac Policy Procedures Manual", dated September 20, 2009, lacks a review approval signature. This inspection revealed your firm is registered with the FDA as a contract sterilizer, but it is operating as a manufacturer of sterile surgical linen products. You must appropriately register your establishment as a manufacturer of medical devices with the FDA. Failure to register

5 list as a device manufacturer is a violation of Section 502(0) of the Act [21 USC 352(0)], since in the devices have been manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under Section 510 of the Act [21 USC 360]. Information on how to register can be found at 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 Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, /or civil money penalties. 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, premarket approval applications for Class III 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 the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay the time within which the corrections will be completed. Your response should be sent to Mark W. Rivero, Compliance Officer, at the above address. If you have any questions about the content of this letter please contact Mr. Rivero at (504) , extension 103. 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 regulations administered by FDA. The specific violations noted in this letter in the Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing quality assurance systems. You should investigate determine the causes of the violations, take prompt action to correct the violations to bring your products into compliance. Sincerely, /S/ Carol S. Sanchez Acting District Director New Orleans District

6 Enclosure: FDA 483 dated July 30, 2009 cc: Paul J. Hickey, General Manager Steripac, Inc nd Street South Birmingham, Alabama 35283