Inspections, Compliance, Enforcement, and Criminal Investigations
Superior Products, Inc. 03-Jan-08
Department of Health and Human Services
Public Health Service
Cincinnati District Office
January 3, 2008
VIA FEDERAL EXPRESS
Doug L. Mottinger
Superior Products, Inc.
3786 Ridge Road
Cleveland, OH 44144-1127
Dear Mr. Mottinger:
During an inspection of your firm located in Cleveland, OH, on October 17 through 31, 2007, an investigator from the United States Food and Drug Administration (FDA)determined that your firm manufactures oxygen conservers and regulators, medical gas regulators, flow meters, humidifiers, and medical gas fittings. 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 manufacturing, 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. We received a response from you on November 30, 2007, concerning our investigator's observations noted on the FDA 483, List of Inspectional Observations that was issued to you. These violations include, but are not limited to, the following:
1) Failure to identify all actions needed to correct and prevent the recurrence of nonconforming product. [21 C.F.R. § 820.100(a)(3)].
Specifically, between April of 2006 and September of 2007, your firm received complaints regarding leaks on 26 of the [redacted] Oxy-Serve 11 oxygen conserving regulators that had been distributed. This represented [redacted]% of the units that have been distributed. Your firm changed the design of the regulators to correct the problem for new regulators manufactured in December of 2006, but did not take any corrective actions to the units that had already been distributed until initiating a recall during this FDA inspection.
We have reviewed your response, and it appears adequate. Please keep us updated on the status of the recall.
2) Failure to review, evaluate, and investigate complaints involving the possible failure of a device to meet its specification. [21 C.F.R. § 820.198(c)].
Specifically, your firm received at least 10 complaints for the Oxy-Serve II regarding gasket leaks, o-rings blowing off, or otherwise improper functioning. There is no documentation that any of these complaints were reviewed, evaluated and investigated.
We have reviewed your response, and it appears adequate. We will verify this corrective action during a future inspection of your firm.
3) Failure to verify or validate corrective and preventive action to ensure such action is effective and does not adversely affect the finished device. [21 C.F.R. § 820.100(a)(4)].
Specifically the groove configuration of the hub regulator and the thickness of the rubber oxygen washer were changed on the Oxy-Serve 11 oxygen conserving regulator. These changes were made due to complaints regarding leaks and your internal testing, which found leaks. These changes we're not verified or validated.
We have reviewed your response and have concluded that it is inadequate because it does not include documented evidence that these changes have been validated. Please provide copies of the validation testing for these changes.
4) Failure to implement your nonconforming product procedure, including failure to adequately control products that do not conform to specifications. [21 C.F.R. § 820.90(a)].
Specifically, the FDA investigator observed several nonconforming products in the assembly area that were not isolated, segregated, or dispositioned in accordance with your Nonconforming product procedure.
We have reviewed your response and have concluded that it is inadequate because it does not include documented evidence that the manufacturing procedures and worksheets have been revised. Please provide copies of these documents.
5) Failure to assure the design for the Oxy-Serve 11 oxygen conserving regulator was developed in accordance with the design control requirements of the QS regulation. [21 C.F.R. § 820.30].
Specifically, the design controls for the Oxy-Serve 11 oxygen conserving regulator are inadequate because of deficiencies including, but not limited to, the following:
" Failure to develop design inputs until over one year after the Oxy-Serve II was released for distribution. The device was released on 11/21/05 and the design input requirements were not drafted until 1/31/07. [21 C.F.R. § 820.30(c)].
" Failure to have a designated individual review and approve the input requirement for the Oxy-Serve II. [21 C.F.R. § 820.30(c)].
" Failure of the design plan to assign responsibility and to identify and describe interfaces with different groups or activities that provide, or result in, input to the design and development process. [21 C.F.R. § 820.30(b)].
" Failure to perform the design shipping (ET2021) and cleaning (ET2019) verification tests for the Oxy-Serve11. Additionally, six of the verification tests were not performed until over a year after the Oxy-Serve lI was released for distribution; and three of the verification test that were performed were incomplete. [21 C.F.R. § 820.30(f)].
Failure to resolve discrepancies and out-of-specification result found during verification testing. For example, 31 of the 345 tests results for flow rate were out of specification. [21 C.F.R. § 820.30(f)].
" Failure to have a protocol to govern the "patient questionnaire", which was used as part of design validation. Additionally, some of the questionnaires had comments regarding the difficulty of the knob/handle to turn. There is no evidence this issue was addressed. [21 C.F.R. § 820.30(g)].
" Failure to perform design reviews at the stages defined in your design control procedure. [21 C.F.R. § 820.30(e)].
We have reviewed your response and have concluded that it is inadequate because it does not include documented evidence that the following have been completed: approval of design inputs; assurance that design plans include responsibility and description of interfaces; verification tests; a risk analysis; evaluation of unresolved discrepancies and out of specification results found during the design phase; and formal design reviews. Please provide copies of the evidence for these corrective actions.
6) Failure to validate a process whose results cannot be fully verified by subsequent inspection and test. [21 C.F.R. § 820.75(a)].
Specifically, the [redacted] mill turn used to manufacture the Oxy-Serve II oxygen conserving regulator has not been validated.
Your response states that you have identified a list of machines that need to be validated. You stated that until operational and performance qualifications are completed there will be no production runs of components for the conserving regulator. Are any other components of medical devices manufactured on these machines? If so, are you also stopping production of those components until validation is complete? Please provide a copy of the list of machines that are being validated. Also, please provide copies of the validation protocols and the operational and performance qualification reports when they are completed. Furthermore, please provide timeframes for when the protocol and actual validation will be completed.
7) Failure to implement your procedure to evaluate and select potential suppliers, contractors and consultants on the basis of their ability to meet specified requirements, including quality requirements. [21 C.F.R. § 820.50(a)(1)].
Specifically, you have no records to show that your three main suppliers have been evaluated and qualify as approved suppliers.
We have reviewed your response which states: all suppliers have been audited or have completed a self audit; your engineering and purchasing departments have rated these vendors; and that you are updating your approved vendor's list. Please provide copies of evidence documenting these corrective actions. Also provide a timeframe for when your approved vendor list will be updated.
8) Failure to establish and maintain procedures to control documents, including procedures to promptly remove from all points of use or otherwise prevent from intended use all obsolete documents. [21 C.F.R. § 820.40(a)]. Specifically,
" Part #PP-2201 has been discontinued and its drawing has not been made obsolete.
" Part #PP-1098 is listed on the bill of materials as Rev N, but on the actual drawing it is listed as Rev P. Your employee stated that although Rev P is approved, it has not been implemented, and Rev N should be used. An employee could use Rev P to manufacture the Oxy-Serve II, because the approved drawing is located in the Device Master Record file.
We have reviewed your response and have concluded that it is inadequate because it does not include documented evidence that all obsolete and unreleased parts have been removed from the device master records.
9) Failure to conduct quality audits at sufficient intervals, as prescribed by your internal procedures, to verify that the quality system is effective in fulfilling your quality system objectives. [21 C.F.R. § 82b.22].
Specifically, your internal audit procedure states to conduct an audit annually. Your firm has not conducted an audit of your quality system for the past five years. Although you are currently conducting an internal audit, only nine of the fifteen identified systems have been audited.
Your response appears adequate. Please provide a copy of the audit schedule, and whether or not audits are being completed according to the schedule.
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 applications for Class III devices to which the Quality System regulation deficiencies 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 within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct these noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation for 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 action 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 Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 167, or you may forward a facsimile to her at (513) 679-2773.
Finally, you should know that this letter is not intended to be an all-inclusive list of 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 to bring your products into compliance.
Carol A. Heppe