Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
March 11, 2014
VIA UPS Next Day
Mr. Benson F. Smith
550 E. Swedes Ford Road, Suite 400
Wayne, PA 19087
Dear Mr. Smith:
During an inspection of your firm located at 900 W. University Dr., Arlington Heights, Illinois, on August 27, 2013, through September 24, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II nebulizer, humidifier, and respiratory gas devices. 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 to affect the structure or any 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. Significant violations include, but are not limited to, the following:
1. Failure to adequately establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example, CAPA (b)(4) was initiated to inspect for seal defects / creased seals. It failed to evaluate whether a corrective action should be initiated for distributed impacted lots. In CAPA (b)(4) the pouch forming filling duration was reduced, your firm failed to fully verify that this corrective action was effective.
2. Failure to document when changes or process deviations occur, your firm must review and evaluate the process and perform revalidation where appropriate. These activities shall be documented as required by 21 CFR 820.75(c). For example, CAPA (b)(4) for the Humidifier Adaptor seals integrity issue, these changes were not validated and your firm has not documented why revalidation is not appropriate.
3. Failure to establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics as required in 21 CFR 820.250(a). For example, your Hudson RCI Humidifier adapter devices manufactured on 08/30/12 were released for distribution on 09/13/12. Seal defects were noted after release for distribution. On 05/03/13 and 05/23/13 lot (b)(4) was 100% visually inspected for creased seals, defects were found and scrapped. Your statistical tool for CAPA data trending is inadequate to assess whether a corrective or preventive action is indicated. For example, your firm did not consistently include all scrapped nonconforming records in the data trend. Approximately (b)(4) humidifier adaptor devices scrapped between 01/10/13 – 05/31/13 for creased seal defects were not included in the non-conforming product data trend.
4. Failure to conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules as required in 21 CFR 820.70(g)(2). For example, there is no evidence to support your PM program of visual inspection as a suitable method to detect out of specification results of the heat plate on the pouch forming station for packaging used to assemble Hudson RCI Humidifier Adaptors. Also, there is no evidence to support visual inspection as a suitable test method to detect out of specification results in your PM program for the forming mold cooling lines of the packaging machine that is used to package assembled Hudson RCI Humidifier Adaptors.
5. Failure to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met, as required in 21 CFR 820.70(g)(1). For example, a form/fill/seal packaging machine used to package assembled Hudson RCI Humidifier Adaptors uses an air cylinder that intermittently advances top film was replaced due to excessive ware on 11/29/12 as a corrective action for CAPA (b)(4) (seal crease integrity issue). As of 09/05/13 your firm had not established an adjustment, cleaning, or maintenance schedule for this air cylinder.
We received written responses dated October 10, 2013, December 9, 2013, and February 26, 2014, from Mr. Michael L. Wolf, Quality Manager, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations that was issued to your firm. We find your responses are inadequate. Two repeat violations were noted from the previous inspection dated April 19 through May 12, 2010. The repeat observations related to your firm’s failure to address causes of non-conforming product and the failure to validate processes. A follow-up inspection by FDA would have to be conducted to assure that corrections and/or corrective actions are in place.
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. Also, 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 (15) 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.
Your firm’s response should be sent to: Matthew Sienko, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS case # 419532) when replying. If you have any questions about the content of this letter, please contact Mr. Sienko at 312-596-4213.
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.
Scott J. MacIntire
Kevin W. Rush, Plant Manager
900 W. University Dr.
Arlington Heights, IL 60004-1824
Michael L. Wolf, Quality Manager
900 W. University Dr.
Arlington Heights, IL 60004-1824