| 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 |
Department of Health and Human ServicesJanuary 19, 2010
WARNING LETTER NO. 2010-NOL-07
FEDERAL EXPRESS
Delivery Signature Requested
Donald L. Haferkamp, President
Crown Health Care Laundry Services, Inc.
1501 North Guillemard Street
Pensacola, Florida 32501
Dear Mr. Haferkamp:
During an inspection of your facility, located at 3501 Alabama Highway 41, Selma, Alabama, on November 17 through 25,2009, investigators from the U. S. Food and Drug Administration (FDA) determined your firm manufactures reusable sterile surgical drape packs. Under Section 201(h) of the Federal Food, Drug, and 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 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). On December 17,2009, we received a response from William J. Sopp, General Manager, Crown Health Care Laundry Services (3501 Alabama Highway 41, Selma, Alabama), concerning our observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, issued to him on November 25, 2009. We address his response below, in relation to each of the noted violations. The violations include, but are not limited to, the following:
1. Failure to establish and maintain 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 2 I CFR 820.22. Furthermore, your firm failed to have the quality audits conducted by individuals who do not have direct responsibility for the matters being audited also required by 21 CFR 820.22. [Reference: FDA 483 Item 1]
Our investigators documented your firm is not conducting audits, as required by your "Management Control System" standard operating procedure (SOP). The procedure requires (b)(4) audits by an independent auditor; however, our investigators found the last two audits were conducted during August 2009 and September 2008 and were conducted by your Corporate Quality Assurance Manager.
Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future inspection.
2. 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). [Reference: FDA 483 Item 2] Your SOP "Management Control System" requires a management individual with executive responsibility to review your quality system and procedures (b)(4) for suitability and effectiveness; however, our investigators found your firm was not adhering to your SOP.
Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future inspection.
3. Failure to document all required corrective and preventive action (CAPA) activities and results, as required by 21 CFR 820.100(b). [Reference: FDA 483 Item 3] According to your "Deviation Log" there were at least 28 instances in which the final exhaust of the surgical pack sterilization cycle fell below the required specification of greater than or equal to (b)(4)" Hg. Sterilization cycle deviation reports documenting only 23 of those instances were available. Your firm failed to document CAPA activities, i.e. trend analyses, investigations into causes of nonconformance, or actions identified to prevent recurrence of the nonconformance, associated with the process deviations.
Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future inspection.
4. Failure to validate processes where the results of a process cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). [Reference: FDA 483 Item 4] For example, your firm has not approved according to established procedures, or validated with a high degree of assurance, the cleaning and drying processes conducted on the operating room towels and sheets.
We reviewed your response and concluded it is inadequate as the cleaning and drying processes, along with sterilization, would be considered parts of the total manufacturing process. The information submitted with your response will be verified along with SOPs and associated process validation data at your firm during a future inspection.
5. Failure to develop, conduct, control, and monitor production processes to ensure each device conforms to its specifications, as required by 21 CFR 820.70(a). [Reference: FDA 483 Item 5] Specifically, your firm does not have process control procedures for the cleaning and drying equipment and manufacturing operations.
We reviewed your response and concluded it is inadequate as procedures relating to the cleaning and drying equipment and operations were not included.
6. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure complaints 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 820.198(a)(3). [Reference: FDA 483 Item 6J Specifically, your complaint form does not include or address whether the complaint requires evaluation for MDR reportability as required by your associated "Complaint Handling System" and "Medical Device Reporting" SOPs.
Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future inspection.
7. Failure to establish and maintain procedures to ensure all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50. [Reference: FDA 483 Item 7] For example, your firm failed to establish purchasing control procedures and to define and implement adequate quality controls which must be met by suppliers and contractors. Additionally, there was no documentation demonstrating your firm is being notified of changes made by contract suppliers. According to a contractor's service report, dated August 31, 2009, a new chemical product was added to the cleaning operation; it does not appear firm management was notified of the change before implementation.
We reviewed your response and concluded it is inadequate as purchasing control procedures relating to the cleaning, drying, and sterilization operations were not included.
8. Failure to maintain device master records (DMRs), as required by 21 CFR 820.181. [Reference: FDA 483 Item 8] Specifically, your firm has not included, or referenced the location of, production and process, quality assurance, or packaging and labeling specifications relating to the reusable sterile surgical drape packs you manufacture. The DMR would include the required information for all stages of the manufacturing process, including cleaning, drying, and sterilizing.
We reviewed your response and concluded it is inadequate because you have not included, or specifically referenced the location of, the missing information.
9. Failure to maintain device history records (DHRs), as required by 21 CFR 820.184. [Reference: FDA 483 Item 9] Specifically, your DHRs do not include records documenting cleaning, drying, packing, or reworking activities.
We reviewed your response and concluded it is inadequate because you have not included required documents, such as records documenting cleaning, drying, packing, or reworking activities.
10. Failure to document acceptance activities, as required by 21 CFR 820.80(e). [Reference: FDA 483 Item 10] For example, your firm failed to document all of the in-process acceptance activities, including incoming linen defect inspections in the pack room and visual wet pack inspections after sterilization.
Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future inspection.
11. Failure to document the final disposition of nonconforming product, as required by 21 CFR 820.90(b)(1). [Reference: FDA 483 Item 11] Specifically, your firm does not document the final disposition or track and trend the number of items returned for rework or sold as rags.
Your response to this observation appears to be adequate. We will verify the adequacy of this corrective action during a future 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/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 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 and the time within which the corrections will be completed.
Your response should be sent to Rebecca A. Asente, Compliance Officer, at the above address. If you have any questions about the content of this letter please contact Ms. Asente at (504) 219-8818, extension 104.
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 conclusion 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 action to correct the violations and to bring your products into compliance.
Sincerely,
/S/
Patricia K. Schafer
Acting District Director
New Orleans District
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