Inspections, Compliance, Enforcement, and Criminal Investigations

Voss Plastics, Inc. 11/5/14

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

November 5, 2014
 
2015-DAL-WL-05
WARNING LETTER
 
UPS Overnight
 
Gene A. Voss, President and Owner
Voss Plastics, Inc.
4235 Centergate Street
San Antonio, Texas 78217
 
Dear Mr. Voss,
 
During an inspection of your firm located at 11630 Rainbow Ridge, Helotes, Texas 78023 on September 8 – 12, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a contract manufacturer of disposable coronary by-pass cannulas.  Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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. These violations include, but are not limited to, the following:
 
1.    Failure to establish procedures for validating a process whose results cannot be fully verified as required by 21 CFR 820.75(a).
 
Specifically, your firm manufactures the disposable coronary by-pass cannulas using an (b)(4) process. This process is not a fully verifiable process and your firm has not established procedures for validating the process. 
 
2.    Failure to establish procedures for developing, conducting, and controlling, and monitoring production processes to ensure device conform to specifications as required by 21 CFR 820.70(a).
 
Specifically, your firm has not establish procedures for the set-up, operation, and monitoring of your (b)(4) process used in the manufacture of the disposable coronary by-pass cannula. Further, your firm’s Plant Manager stated he visually inspects individual units during the run to verify the device is manufactured correctly; however, you firm does not have written procedures identifying how this visual inspection would be conducted and does not specify when and how often samples will be pulled.
 
3.    Failure to establish acceptance activities for the manufacture of your disposable coronary by-pass cannulas as required by 21 CFR 80(a).
 
Specifically, your firm has not established procedures for the receiving, in-process, or finished product acceptance activities which occur during your manufacturing of your disposable coronary by-pass cannulas. Your firm has not established procedures documenting how these activities will be performed or how the results of the activities will be documented and approved.
 
4.    Failure to establish procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90(a).
 
Specifically, your firm has not established procedures to identify, document, evaluate, segregate, and disposition nonconforming products.
 
5.    Failure to establish procedures for corrective and preventive actions as required by 21 CFR 820.100(a).
 
Specifically, your firm has not established procedures for analyzing product process and quality data, investigating causes of nonconformities, identifying actions needed to correct and prevent recurrence of nonconformities, verifying or validating the corrective or preventive actions to ensure the action is effective, implementing and recording changes in methods and procedures needed to correct and prevent identified quality issues, ensuring information related to quality problems is disseminated to those responsible for assuring the quality of the product, and submitting relevant information on identified quality problems for management review.
 
6.    Failure to establish procedures reviewing and evaluating complaints as required by 21 CFR 820.198(a). 
 
Specifically, your firm has not established procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
 
7.    Failure to establish procedures to maintain device history records as required by 21 CFR 820.184.
 
Specifically, your firm has not established procedures to ensure device history records for each batch, lot, or unit of your disposable coronary by-pass cannula are maintained to demonstrate the devices were manufactured in accordance with your established specifications and the requirements of 21 CFR 820.
8.    Failure to establish procedures for quality audits as required by 21 CFR 820.22.
 
Specifically, your firm has not established procedures for conducting quality audits.
 
9.    Failure to establish procedures for management reviews required by 21 CFR 820.20(c). 
 
Specifically, your firm has not established procedures for conducting management reviews.
 
We received a response letter dated September 17, 2014 from your Vice President and CEO. Our review found the response was inadequate. Although you indicate you will correct the deviations through the generation of new procedures, you did not provide copies of the procedures or sufficient detail of the content of the procedures for our review. We acknowledge in your firm’s response you indicate you will not be (b)(4); however, corrections to the deficiencies identified above should be completed prior to manufacturing the products. 
 
MEDICAL DEVICE REPORTING
 
Our inspection also revealed that your firm’s disposable coronary by-pass devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C.   § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting.  Significant violations include, but are not limited to, the following:
 
Failure of your firm to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
 
Specifically, your firm does not have any written MDR procedures.
 
Our review of your response found the response was inadequate. Although you indicate you will correct the deviation through the generation of new procedures no written MDR procedure was provided.
 
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 (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: Dallas District Office, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204. If you have any questions about the contents of this letter, please contact: Jeff R. Wooley at 214-253-5251.
 
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/                                                          
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
 
CC:
 
Sara Voss Weyman, Chief Executive Officer
Voss Plastics, Inc.
11630 Rainbow Ridge
Helotes, Texas 78023

 

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