Inspections, Compliance, Enforcement, and Criminal Investigations

Royal Case Co., Inc. 7/30/15

  

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

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas. Texas 75204 

 

July 30, 2015
 
2015-DAL-WL-25
 
 
            WARNING LETTER
 
 
UPS OVERNIGHT
 
Zoltan M. Pocza, Sr.
Chief Executive Officer
Royal Case Company, Inc.
419 East Lamar
Sherman, Texas 75090
 
Dear Mr. Pocza:
 
During an inspection of your firm located in Sherman, Texas on June 29, 2015 through July 1, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures (i.e., initially imports) Cutaneous Electrode Garments.  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 from David Shamasko, President, dated July 15, 2015 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, that was issued to your firm. We address this response below. These violations include, but are not limited to, the following:
 
Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
 
Specifically, for the cutaneous electrode garment device that your firm initially imports, procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not include any information to demonstrate that a Complaint Handling procedure would be established by your firm.
 
Our inspection revealed that your firm’s cutaneous electrode garment devices, which you initially import, 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 to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
 
Specifically, for the cutaneous electrode garment device that your firm initially imports, your firm does not have any written MDR procedures.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not include any information to demonstrate that a MDR procedure would be established by your firm.
 
A follow up inspection may be required to assure that corrections and/or corrective actions are adequate. 
 
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. 
 
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.
 
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: John W. Diehl at 214-253-5288.
 
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:
 
David Shamasko, President
Royal Case Company, Inc.
419 East Lamar
Sherman, Texas 75090
 
Zoltan M. Pocza, Jr.
Vice President
Royal Case Company, Inc.
419 East Lamar
Sherman, Texas 75090
 
Tom Brinck, Manager
Drugs and Medical Devices Group
Texas Department of State Health Services
8407 Wall Street, S-124
Austin, Texas 78714

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