Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm365433
Timestamp: 2019-02-23 21:39:55
Document Index: 497675965

Matched Legal Cases: ['§ 321', '§ 351', 'art 820', 'art 803', '§ 351', '§ 360', '§ 360', '§ 352', '§ 360']

Zeppessis Reprocessing, LLC 8/9/13
In reply refer to Warning Letter SEA 13-25
Vern R. Williams, Owner/Operator
121 East 38th Street, Suite 101
During an inspection of your firm located in Garden City, Idaho on April 08, 2013, through April 11, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm reprocesses the Stryker Neptune 1 and 2 Waste Management System manifolds. 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. We received your response dated May 1, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example:
a. Your firm’s 7-step cleaning protocol for reprocessing used manifolds has not been validated to provide demonstrated assurance that the reprocessed manifolds will consistently meet specified requirements.
b. The directions for use in the (b)(4) Industrial Degreaser, sometimes used in conjunction with the (b)(4) Multi Enzyme detergent, does not list a medical application. Your firm has not evaluated or validated the use of the industrial degreaser in reprocessing used manifolds.
c. The indications for use of the high level disinfectant Cidex® OPA-C states that it is not intended for manual use. Your firm has not evaluated or validated the manual use of the Cidex® OPA-C in the reprocessing of used manifolds.
d. Your firm adds a rubber o-ring between the upper and lower casings of reprocessed manifolds that is absent on the manifolds supplied by the original manufacturer. Your firm has not evaluated or validated the use of the rubber o-ring to demonstrate it does not negatively affect the functionality of the reprocessed manifolds when compared to new manifolds. Your firm has received at least one complaint alleging it used an oversized o-ring which was causing a manifold your firm reprocessed to jam inside a Stryker Neptune waste management system machine.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not perform a validation on the functional properties of the manifolds including the functionality of the reflux prevention valve after reprocessing up to four times. Your firm stated on pg. 16 of its Policies and Procedures provided with the response, that manifolds are “non-critical”. However, if the manifold reflux prevention valve fails, collected fluid may reflux back into the patient. The validation does not provide assurance that the reflux prevention valve is functional following reprocessing four times. Additionally, your firm stated that it discontinued the use of the industrial degreaser but it uses bleach, (b)(4), and Cidex® OPA-C. Your firm failed to validate the use of these cleaning products on the functional properties of reprocessed manifolds.
Failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm reported to the FDA investigator that it received a complaint regarding use of an oversized O-ring, which caused the manifold to lodge inside the Stryker Neptune waste management machine. Your firm did not document receipt of this complaint or any actions taken as a result of the complaint.
We reviewed your firm’s response and conclude that it is not adequate. The procedure submitted for this observation and the accompanying Complaint Form do not include all the information required by the regulations. Your response did not address the requirement that complaints shall be evaluated to determine their reportability under 21 CFR Part 803, Medical Device Reporting; the Complaint Form neither captures the name of the individual recording the complaint nor any device identification.
Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, the culture performed on your firm’s reprocessed manifold by (b)(4), with report date August 17, 2012, reveals a Bacillus count of (b)(4) colonies. Your firm’s informal specification for the cleanliness of the manifolds it reprocesses requires the results of 48-hour cultures to be less than (b)(4) colonies. Your firm does not have documentation that it:
a. Investigated the cause of the nonconformity.
b. Identified the actions needed to correct and prevent recurrence of the nonconformity.
c. Took any action to correct the cause of the nonconformity.
d. Verified and/or validated the effectiveness of the corrective actions taken.
We reviewed your firm’s response and conclude that it is not adequate. The Corrective and Preventive Action procedure submitted by your firm does not include requirements for analyzing quality data, investigating the cause of nonconformities, identifying actions to correct and prevent recurrence of quality problems, verifying or validating the actions, implementing and recording changes to records and procedures needed to correct and prevent identified quality problems, disseminating information to responsible individuals, submitting information to management review, and documenting all activities.
a. The indications for use of the high level disinfectant Cidex® OPA-C (ortho phthalaldehyde concentrate) used by your firm to reprocess manifolds requires contact time of (b)(4) minutes at (b)(4)ºC ((b)(4)ºF) for a (b)(4)% solution. Your firm’s cleaning instructions placard requires (b)(4) minutes at (b)(4)ºC or (b)(4) minutes at (b)(4)ºC for (b)(4)% solution Cidex® OPA-C. During the inspection, the investigator observed your firm use a soak time of (b)(4) minutes at (b)(4)ºC ((b)(4)ºF) in a (b)(4)% solution of Cidex® OPA-C.
b. Your firm does not maintain a record of the water temperature during the reprocessing of manifolds.
We reviewed your firm’s response and conclude that it is not adequate. Your firm submitted a Process Flow diagram that: did not define how the sinks are to be cleaned after processing; did not define the source of water and level of purity used in the cleaning process; and did not define the amount of water to be added to each sink. Your firm indicates in the placard collected during the inspection that it is (b)(4) gallons per sink.
Concerns with Step 1 include the following:
i. The instructions for Step 1 include a minimum (b)(4) minutes soak time dependent on soil level. Your firm does not specify how to assess the soil level or if the soil is heavy, what the maximum soak time should be.
ii. Step 1 also calls for the use of bleach. However, it does not define how to make the bleach solution, specify the required active chlorine, or test for active chlorine; and
iii. There is also a temperature maximum of no greater than (b)(4)°C but there is no reference to a minimum temperature.
Step 2, also requires the use of bleach. However, it does not define how to make the bleach solution, specify the required active chlorine, or test for active chlorine.
Concerns with Step 3 include the following:
i. Specifically, Basin (b)(4) in this step requires both time and temperature to be controlled to meet Cidex® OPA-C Instructions for Use (IFU); however it is not defined how the temperature will be controlled.
ii. It includes time and temperature for exposure to Cidex® OPA-C of (b)(4)°C for (b)(4) minutes which is the time and temperature in the Cidex ® OPA-C IFU for automated endoscope cleaning, not manual cleaning; and
iii. It states in Step 3 that full strength ingredient is used but do not state the concentration of the primary ingredient or how it is calculated. In the placard collected during the inspection, you state that (b)(4) gallons of water are added to sink (b)(4).
Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example, your firm has not defined or documented the acceptance criteria for the release of the reprocessed manifolds. Your firm has not documented its informal specification for the cleanliness of the manifolds it reprocesses which requires the results of 48-hour cultures to be less than (b)(4) colonies.
Your firm’s response to this observation appears to be adequate. Your firm has established a definition for an accepted finished device. Your firm has provided its procedure, “Policies and Procedures for Finished Device Acceptance” for review. Further, you state that you will no longer utilize routine cultures to validate the cleaning process. You also provided the SOP for the details of the current validation methodology. Your response will be verified in conjunction with your operations during the next inspection.
Failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution, as required by 21 CFR 820.160(a). For example, your firm does not maintain a procedure for the distribution of the reprocessed manifolds to include or refer to the location of the name and address of the initial consignee, the identification and quantity of devices shipped, and the date shipped.
Your firm’s response to this observation appears to be adequate. Your firm has provided its established policy to control and distribute the finished manifolds. The policy states that all batches of manifolds will be accompanied by the incoming shipping label as well as a Process Record Log unique to that batch. The Process Record Log documents the name and address of the initial customer, the identification and quantity of the manifolds shipped, as well as the date of the shipment. Your response will be verified in conjunction with your operations during the next inspection.
Failure to maintain device master records (DMRs) and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181. For example, your firm has not established a DMR for the manifolds it reprocesses. Your firm does not maintain or refer to the location of the following documents: Device, component, and software specifications; and Quality Assurance procedures and specifications, including acceptance criteria.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not specifically identify the records included in its DMRs or provide any information to indicate that it maintains DMRs.
Failure to maintain device history records (DHRs) and establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of 21 CFR 820, as required by 21 CFR 820.184. For example, your firm does not maintain production records for: individual, or lots of reprocessed manifolds which contain or refer to the quantity of devices released for distribution; acceptance records; and any device serial numbers used.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not specifically identify the records included in its DHRs or provide any information to indicate that it maintains DHRs.
Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, your firm has never conducted any quality audits.
We reviewed your firm’s response and conclude that it is not adequate. The Quality Audit procedure provided in the response does not include the requirement that the quality audit be conducted by individuals without direct responsibility for the matters being audited.
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 does not have a written document control procedure that includes the designation of an individual(s) to review and approve all documents and changes to documents required by the Quality System Regulation. Your firm’s cleaning instruction documentation does not have initial approval or approval of a change to the units on the amount of Sodium Hypochlorate to be added to the solution in the first step of the process. The amount of Sodium Hypochlorate was changed from (b)(4) ounces to (b)(4) milliliters on the cleaning instruction placard and did not have documentation of approval for the change.
Your firm’s response to this observation appears to be adequate. Your firm provided its established document control procedures that require signature and the date of management approval. All changes to any form or document will require management sign off and dating. Your response will be verified in conjunction with your operations during the next inspection.
Failure to establish quality system procedures and instructions, as required by 21 CFR 820.20(e). For example, your firm reprocesses and distributes approximately (b)(4) used Stryker Neptune 1 and 2 manifolds per month but has not defined, documented, and implemented procedures and instructions to ensure compliance with each aspect of 21 CFR 820.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s Policies and Procedures document provided with your response does not meet all the requirements of 21 CFR 820. Additionally, you did not provide documentation of the implementation of any proposed procedures included in the response.
FDA also learned that your firm is distributing the reprocessed Stryker Neptune 1 and 2 Waste Management System manifolds without clearance or approval. The manifolds are components of Class II devices, which require a premarket submission clearance in order to be legally marketed. Reprocessing of sterile, “single use only” components also requires that these Class II devices receive 510(k) clearance before it is introduced into interstate commerce.
Therefore, the reprocessed Stryker Neptune 1 and 2 single-port and four-port manifolds are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the devices is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our inspection determined that your firm’s devices are misbranded in that they are not labeled in compliance with Section 502(v) of the Act, 21 U.S.C. 352(v). In addition to generally applicable labeling requirements, Section 502(v) of the Act requires that reprocessed single use devices (SUDs) that are introduced into interstate commerce after January 26, 2004, must prominently and conspicuously bear the following statement on all labeling: "Reprocessed device for single use. Reprocessed by [insert the name of the manufacturer that reprocessed the device]." Your firm applies a label to manifolds following reprocessing that reads “Zeppessis Reprocessing” and your firm includes a green reprocess label sheet in the tote that holds the manifolds that also reads “Zeppessis Reprocessing”. Neither of these labels includes the statement required by Section 502(v) of the Act; causing your devices to be misbranded.
Your firm’s response should be sent to: Brenda L. Reihing, Compliance Officer, U.S. Food and Drug Administration, Seattle District Office, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. Refer to WL SEA 13-25 when replying. If you have any questions about the contents of this letter, please contact: Brenda L. Reihing, Compliance Officer at 425-302-0429.
Celeste M. Corcoran