WARNING LETTER

International Hospital Products, Inc. MARCS-CMS 579332 — May 29, 2019

Delivery Method:: United Parcel Service
Product:: Medical Devices

Recipient:: Recipient Name

Drew O. Murphy; Recipient Title

Owner; International Hospital Products, Inc.; 2783 W Long Drive, Unit B
Littleton, CO 80163
United States

Issuing Office:: Division of Medical Device and Radiological Health Operations West; 19701 Fairchild
Irvine, CA 92612-2506
United States

WARNING LETTER

CMS # 579332

UNITED PARCEL SERVICE

OVERNIGHT DELIVERY

May 29, 2019

International Hospital Products, Inc.

Drew O. Murphy, Owner

2783 W Long Drive, Unit B

Littleton, CO 80163

Dear Ms. Murphy:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 2783 W Long Drive, Unit B, in Littleton, CO from March 15-19, 2019. During the inspection, an FDA investigator determined that your firm is a manufacturer (specification developer) of Class II Baker Jejunostomy and intestinal tubes used for bowel decompression. 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 a response dated March 25, 2019 from your firm concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations (FDA 483) that was issued on March 19, 2019. Your response stated the Agency could anticipate another response within 90 days, and no additional information or supporting documentation of corrections was provided. Without objective evidence to verify corrections, your response is inadequate. For your reference, FDA defines “establish” under 21 CFR Part 820.3(k) as “define, document (in writing or electronically), and implement.” These violations include, but are not limited to, the following:

1. Process Validation activities and results have not been adequately documented and adequately approved per the requirements of 21 CFR Part 820.75(a).

During our inspection, you did not provide a documented procedure to meet the requirements of 21 CFR Part 820.75 covering process validation. Your firm contracts out the assembly, pouch sealing, and (b)(4) sterilization of your Class II Jejunostomy and intestinal tubes. These devices are used to decompress the bowel and per your IFU, can be left inside the bowel for 7-10 days following decompression. Your products are labeled as sterile.

Our investigator requested documentation to demonstrate process validation was done for the (b)(4) sterilization process. The documents provided show an equivalency study between sterilization chambers to validate a new chamber for use in the year 2003, demonstrating equivalency to a chamber validated in the year 2000. This does not constitute validation of the overall (b)(4) process, but only compares the two chambers. You told our investigator you were not aware of any additional sterilization validation performed for your products since that time.

In addition, the critical parameters listed in this study do not all match the parameters listed in the “Sterilization Cycle Parameter Sheet” signed on 10/27/2003, or the sterilization run record signed 1/18/2018 for sterilization lot (b)(4) covering IHP lots (b)(4) and (b)(4) under (b)(4). There appear to be differences in at least the (b)(4) tested during the study versus the specification that was approved. Bioburden levels were assessed, however at the time of the study, the devices were manufactured by a different supplier. Therefore, these levels cannot be assumed correct using your new contract assembly supplier and would need to be reassessed for each supplier change. In addition, at least a portion of the (b)(4) data for this study was lost due to power failure, as documented by a memo to file.

Packaging is critical to ensure maintaining a barrier to protect sterile product. Our investigator requested documentation to demonstrate process validation was done for package sealing of your sterile products. The documentation provided consisted of some data charts, but no context to show validation was performed per a protocol with pre-approved acceptance criteria, test data, or any final report to confirm the sealing process can maintain sterility barrier.

The documentation maintained by your firm does not demonstrate a validation was performed to a high degree of assurance for the (b)(4) sterilization or packaging processes. Please review the requirements of 21 CFR Part 820.75 and provide information as to how you are ensuring sterilization and maintaining that sterilization for your products currently being distributed and in future. We also request that you establish procedures to meet the requirements, and implement those procedures to include retention of applicable records. Please provide our office a timeframe for when this can be completed, a copy of the procedure once it is in place, and records such as the final report showing results of each validation.

2. Procedures for finished device acceptance have not been established per the requirements of 21 CFR Part 820.80(d).

During our inspection, you told our investigator that you visually inspect incoming devices, but do not have a documented process in place which covers what sort of defects you review for, and stated you do not document this visual inspection. Our investigator reviewed other records onsite and found you did not have records to confirm sterility of the lots you are currently distributing for your device which can be left inside the bowel for 7-10 days following decompression.

The documentation maintained by your firm is insufficient to show your undocumented device acceptance policy meets the requirements of 21 CFR Part 820.80. We ask that you review this section, establish procedures to meet the requirements, and implement those procedures to include retention of applicable records. Please provide our office a timeframe for when this can be completed, a copy of the procedure once it is in place, and an example of records that demonstrate implementation of your new procedure.

3. Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established per the requirements of 21 CFR Part 820.50.

During our inspection, you stated you do not have a procedure established to evaluate suppliers for the contract manufacture or sterilization of your Class II Jejunostomy and intestinal tubes which are labeled as sterile. You stated you have been using your contract manufacturer since May 2017 and had no records to show a documented review of this supplier except for a print out of their ISO certificate. You stated you have been using your contract sterilizer since before the time the firm moved from its prior location in 2013, and had once visited their facility, but had not documented your visit nor had knowledge of the quality system requirements at the time of that visit. Therefore, you stated you had also not evaluated this contract manufacturer.

In addition, you provided what you described as “obsolete” specifications for three product numbers during our inspection (b)(4). You also provided “current” specifications for six product numbers (b)(4) which do not note your review or approval. After review of these documents, you contacted your contract manufacturer to clarify what revisions of drawings they are using for production. Upon review of the certificates of conformance you receive from your contract manufacturer, it was determined the revisions listed on those certificates were not consistent with the current corresponding specification drawing revisions because your contract manufacturer had been using a previous supplier’s drawings in production. Part of the regulations covering purchasing includes a potential agreement where suppliers, such as your contract manufacturer, must make you aware of changes prior to implementing them. Such an agreement might have been of benefit in this situation.

We ask that you review 21 CFR Part 820.50, establish procedures to meet the requirements, and implement those procedures to include retention of applicable records. Please be aware in your review of this section that the regulation also applies to consultants. We request that you provide our office a timeframe when this is completed, a copy of the procedure once it is in place, and an example of records showing the new procedure has adequately corrected this issue.

4. A device master record has not been maintained, per the requirements of 21 CFR Part 820.181.

During our inspection, you could not provide a Device Master Record (DMR) for your Class II Jejunostomy and intestinal tubes. A DMR is a compilation of specifications for design, production, quality assurance, packaging, etc. which helps to ensure a medical device is manufactured according to the most current specifications and applicable procedures.

Per the discussion in item 3 above, during our inspection you provided specifications which were not current as to what was being used by your contract manufacturer to manufacture your products. Having a DMR in place would provide all current specifications in one place and this document should be updated as various specifications are updated. We ask that you review the requirements of 21 CFR Part 820.181 and provide a copy of the DMR showing the list of specifications when complete, but not necessarily all related documents which will need to be reviewed during your next inspection.

5. Procedures for design change have not been established, per the requirements of 21 CFR Part 820.30(i).

During our inspection, you told our investigator you do not have a procedure governing design changes for your Class II Jejunostomy and intestinal tubes. Although these are pre-amendment devices, changes can still occur over the life cycle of the device, and such changes should be controlled and documented, as well as verified and or validated, reviewed, and approved before they are implemented. According to our preamble to 21 CFR Part 820, “since early 1984, FDA has identified lack of design controls as one of the major causes of device recalls… Design changes should be controlled through a design controls process to ensure the changes are appropriate and that the device will continue to perform as intended… The records of these changes create a history of the evolution of the design which can be invaluable for failure investigation and for facilitating the design of future similar products. Such records can prevent the repetition of errors and the development of unsafe or ineffective design. The evaluation and documentation should be in direct proportion to the significance of the change.”

Additionally, as noted in item 3, your contract manufacturer did not have what you described as the current specifications. Therefore, you should also review your procedures covering design transfer (21 CFR Part 820.30) to ensure they are adequately established.

We have included an FDA guidance document titled “Design Control Guidance for Medical Device Manufacturers” to assist in your corrections. We ask that you review this guidance as well as 21 CFR Part 820.30, establish procedures to meet the requirements, and implement those procedures to include retention of applicable records. Please provide our office a timeframe for when this can be completed, a copy of the procedure once it is in place, and a list of any design changes to which you are applying this procedure.

6. Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established per the requirements of 21 CFR Part 820.198.

During our inspection, you stated your firm does not have an established complaint handling procedure, and has never received a complaint. For reference, the Agency defines a complaint under 21 CFR Part 820.3(b). Your firm should review this definition and the requirements of 21 CFR Part 820.198 and establish a procedure to meet these regulatory requirements. We request that you notify our office when this procedure has been established and provide a copy of the procedure along with a few examples showing how you have implemented this procedure. Your procedure should include how you will keep complaint files organized so they are readily accessible during your next inspection.

7. A device history record has not been maintained per the requirements of 21 CFR Part 820.184.

During our inspection, you could not provide an established procedure that governs how Device History Records (DHRs) are maintained and would demonstrate your devices are manufactured in accordance with your current specifications listed in your DMR (which your firm also does not have for your products, per item 4 of this letter). You provided a few records on hand for review including certificates of conformance and sterilization records. As discussed above, some of the conformance records listed different specification revisions than those you had on record yet you distributed these products. In addition, the sterilization records on hand were incomplete, had some differing specifications per item 1, and did not include what product item numbers were included in the sterilization run.

We request that you review the requirements of 21 CFR Part 820.184 and establish a procedure to meet these requirements. Please notify our office when this procedure has been implemented and provide a copy as well as an example of a completed DHR.

8. Procedures have not been established to control product that does not conform to specified requirements per 21 CFR Part 820.90.

During our inspection you stated you do not have established procedures for controlling product that does not conform to specified requirement.

Nonconformity is defined in 21 CFR Part 820.3(q). We request that you review this definition and all requirements of 21 CFR Part 820.90 and establish procedures to meet these requirements. We request that you notify our office when the procedure has been fully implemented including recording nonconformance records as appropriate. Please provide a copy of the new procedure and a few examples of how this procedure has been implemented.

9. Procedures for quality audits have not been established per 21 CFR Part 820.22.

During our inspection you stated you have not established procedures for quality audits and you stated you have not conducted any quality audits of your quality system.

Per the preamble to 21 CFR Part 820, quality “audits may be conducted in phases, with some areas requiring more frequent audits than other areas, and that each audit need not review the whole system. The frequency of internal quality audits should be commensurate with, among other things, the importance of the activity, the difficulty of the activity to perform, and the problems found… if conducted properly, internal quality audits can prevent major problems from developing and provide a foundation for the management review…”

We request that you review the requirements of 21 CFR Part 820.22 and establish a procedure that meets all regulatory requirements. Please provide us a copy of the new procedure, the date and evidence of when your first audit has been completed, and be prepared to show evidence of the audit (but not the results) as well as your overall audit plan during your next inspection.

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 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 (which must address systemic problems) 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.

If you have questions regarding any issues in this letter, please contact Compliance Officer, Lauren Priest at 303-236-9663 or at Lauren.Priest@fda.hhs.gov. Please send your reply electronically to oradevices3firmresponse@fda.hhs.gov.

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.

Sincerely,

/S/

Shari J. Shambaugh

Program Division Director

Office of Medical Device and Radiological Health

Division 3/West