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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Marlen Manufacturing & Development Co. 8/28/09


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761

August 28, 2009



Gary H. Fenton, President
Marlen Manufacturing & Development Co.
5150 Richmond Road
Bedford, OH 44146-1131

Dear Mr, Fenton:

During an inspection of your firm located in Bedford, Ohio, on June 25 through July 8, 2009 a Consumer Safety Officer (CSO) from the United States Food and Drug Administration (FDA) determined that your firm manufactures colostomy bags and colostomy rods. 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, their manufacturing, packing, storage, or installation are not in conformance 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 your response, dated July 23, 2009 to our CSO's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. Your response was inadequate. The violations include, but are not limited to, the following:

1. Failure to maintain complete complaint files documenting an investigation of the root cause or documenting the reason for not investigating, a determination if the complaint is a Medical Device Reportable event, and evidence of review/closure of the complaint as required by 21 CFR 820.198(a). For example, 35 out of 35 complaint files reviewed since 1/2008 were incomplete in that none of the complaint files have a documented root cause. Specific examples include:

• Complaint file dated 1/12/09 documents a leaking seal on an ileostomy gas relief pouch (item number GR-22-203) with no further documentation in this file.

• Complaint file dated 1/19/09 documents an ileostomy pouch (item number MDW-10201) not sealed and leaking between layers with no further documentation in this file.

• Complaint file dated 2/2/09 documents valve caps were cracked on Ultralite urostomy pouches (item number 77153) with no further documentation in this file.

2. Failure to validate and approve a process whose results cannot be fully verified by subsequent inspection and testing as required by 21 CFR 820.75(a). For example, you have not validated:

• The 10 sealing machines used to manufacture various types of ostomy pouches and valves. Variables include, seal temperature, dwell time, pressure, and cooling time.

• The 3 injection molding machines used to manufacture colostomy rods and accessories/components for various types of ostomy bags. Variables include temperature, cycle time, injection time and pressure.

• The vacuum mold machine used to manufacture packaging for the Ultralite ostomy products. Variables include time, temperature and pressure.

3. Failure to develop, implement and maintain written procedures for the reporting of deaths, serious injuries and certain malfunctions as required by 21 CFR 803.17.

4. Failure to fully monitor and control production process parameters as required by 21 CFR 820.70(a)(2). For example you have procedures which describe different process parameters (i.e. time, pressure, temperature, for injection molding, sealing and vacuum forming depending on which product is to be manufactured but you are not documenting the machine settings of these variables on the manufacturing equipment.

5. Failure to adequately inspect or test the plastic films used to manufacture ostomy bags to assure conformance with your specifications as required by 21 CFR 820.80(b).

6. Failure to assure that you have not distributed devices that have deteriorated beyond acceptable fitness for use as required by 21 CFR 820.160(a). For example, one of the components used in manufacturing hundreds of different products in the "Ultralite" line including different variations of colostomy, urostomy and ileostomy pouches is at (b)(4). According to the manufacturer's specifications for this product (b)(4), the component has a 3 year shelf life when stored at 70 F, 50% relative humidity and out of direct sunlight. You used this information to establish and label a 3 year shelf life for their products, but you did not include a temperature or humidity requirement on your label and have not performed any in-house validation activities to support the expiration date of the products.

7. Failure to include in the device history record the number of devices manufactured as required by CFR 820.184(b). For example, a review of 5 out of 5 device history records covering all colostomy rods manufactured over the past two years showed that none of the records documented the quantity of devices manufactured; the quantity released for distribution or contained a copy of the label.

8. Failure to adequately calibrate equipment used in the manufacturing process as required by 21 CFR 820.72(a). For example, your procedures require that a micrometer used to determine material acceptance is to be calibrated twice per year however; this equipment was last calibrated 7/21/08.

9. Failure to conduct management reviews of the quality system as required by 21 CFR 820.20(c).

The above-stated inspection also revealed that your devices are misbranded within the meaning of section 502(t)(2) of the Act [21 U.S.C. 352(t)(2)] in that your film failed to furnish material or information required under section 519 of the Act and the Medical Device Reporting (MDR) Regulation, Title 21, Code of Federal Regulations, Part 803 (21 CFR Part 803). Specifically, you failed to develop, implement and maintain written procedures for the reporting of deaths, serious injuries and certain malfunctions as required by 21 CFR 803.17.

We have reviewed your letter dated July 23, 2009. The letter does not provide any specific detailed corrective action steps regarding these issues. Additionally, you have not provided any supporting documentation.

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.

Federal agencies are advised of the issuance of all Warning Letters about medical 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 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 fifteen 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 violation(s), from occurring again. Include documentation of the corrective action 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 fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to Mr. Stephen J. Rabe, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the content of this letter, please contact Mr. Rabe at (513) 679-2700, extension 163, or you may forward a facsimile to him at (513) 679-2773.

Finally, you should know that 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 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 and to bring your products into compliance.


Teresa C. Thompson
District Director 
Cincinnati District