| Public Health Service Food and Drug Administration |
Dallas District |
Department of Health and Human Services
August 24, 2011
2011-DAL-WL-16
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Richard C. Samaniego, President
Sam-Go Products
108 Oakwood Court
Fort Worth, TX 76135
Dear Mr. Samaniego:
During an inspection of your firm located in Fort Worth, Texas,on March 8, 2011, through March 15, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Nex-Gen Clear Surgical Masks and Nex-Gen Respirator Masks 2-Filter Series. 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 manufacture, packing, storage, or installation are not in conformity 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 a response from you, Mr. Richard C. Samaniego, President, dated March 28, 2011, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the devices in order to ensure that specified design requirements are met, as required by 21 CFR 820.30.
For example, your firm has not established procedures for design input, design output, design verification, design review, or design transfer for the Nex-Gen Clear Surgical Mask and Nex-Gen Clear Respirator Mask 2-Filter Series.
2. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
For example, your Quality Manual required criteria for the selection, evaluation and re-evaluation of suppliers and subcontractors and approval of purchase orders prior to transmission. You did not have documented requirements, including quality requirements that must be met by suppliers; or records to support that supplier evaluations were conducted for suppliers of the filters, masks, T-connectors and clamp components, or that purchase orders were reviewed and approved for these components.
3. Failure to document acceptance activities required by 21 CFR Part 820, including the acceptance activities performed, the dates acceptance activities are performed, the results, the signature of the individual(s) conducting the acceptance activities, and where appropriate the equipment used, as required by 21 CFR 820.80(e).
For example, your firm did not document acceptance activities for receiving, in-process and finished device acceptance. Your firm did not have verification records for purchased incoming product, as required by your Quality Manual. Supplier filter testing was the final acceptance for your firm’s Nex-Gen Clear Surgical Masks, however, your firm did not receive documentation of this testing from the supplier. Your firm conducted a visual inspection of the devices for final acceptance, however, there is no established procedure for this activity and this inspection is not documented.
4. 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).
For example, your firm does not have a procedure addressing complaint handling activities, such as ensuring that complaints are processed in a uniform and timely manner; oral complaints are documented upon receipt; and that complaints are evaluated to determine whether the complaint represents an event required to be reported under 21 CFR Part 803 (Medical Device Reporting).
5. Failure to establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a).
For example, your firm does not have a procedure for handling nonconforming products, including the evaluation, segregation, and disposition of nonconforming product.
6. Failure to establish procedures for management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR Part 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c).
For example, your firm does not have procedures for management review. Sam-Go Products has been manufacturing the Nex-Gen Clear Surgical Mask and the Nex-Gen Clear Respirator Mask 2-Filter Series since January, 2010, but at the time of the inspection, no management reviews have been conducted.
7. 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 does not have procedures addressing Quality Audits. Sam-Go Products has been manufacturing the Nex-Gen Clear Surgical Mask and the Nex-Gen Clear Respirator Mask 2-Filter Series since January, 2010, but at the time of the inspection, no Quality Audits have been conducted.
8. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b). The plans shall be reviewed, updated, and approved as design and development evolves.
For example, for your devices, no design and development plan was documented, reviewed, updated, and approved as the design and development evolved.
9. Failure to maintain Device Master Records (DMR’s) for each type of device to include, or refer to the location of: device specifications, production process specifications, quality assurance procedures and specifications, and packaging and labeling specifications, as required by 21 CFR 820.181.
For example, your firm did not have DMR’s for the Nex-Gen Clear Surgical Masks and Nex-Gen Respirator Masks 2-Filters Series devices.
10. Failure to establish and maintain procedures to ensure that Device History Records (DHR's) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of 21 CFR Part 820, as required by 21 CFR 820.184. The DHR’s shall include, or refer to the location of: the dates of manufacture, the quantity manufactured, the quantity released for distribution, the acceptance records which demonstrate that the devices are manufactured in accordance with the DMR, and the primary identification label and labeling used for each production unit.
For example, your firm has not established and maintained DHR procedures for the Nex-Gen Clear Surgical Masks and the Nex-Gen Clear Respirator Masks 2-Filter Series to ensure DHR’s are maintained to demonstrate that the devices are manufactured in accordance with the DMR. Your firm has not maintained DHR’s that include (or refer to the location of) the dates of manufacture, quantity manufactured, quantity released for distribution, and primary identification label and labeling. Additionally, your firm has not maintained DHR’s that include, or reference the location of, acceptance records for the filters, masks, T-connectors and clamps supplied by your suppliers.
11. Failure to maintain distribution records which include or refer to the location of the name and address of the initial consignee, the identification and quantity of devices shipped, the date shipped, and any control number(s) used, as required by 21 CFR 820.160(b).
For example, your firm did not maintain distribution records for all of the Nex-Gen Clear Surgical Masks and Nex-Gen Respirator Masks 2-Filters Series devices that were distributed since January, 2010.
We have reviewed your response to the observations listed on the FDA 483 and have concluded that it is inadequate. Your response said you will correct in a timely manner all observations that the investigator observed during the inspection. However, the response did not specify what corrective actions you would take to address the noted violations, you did not include documentation to show that corrective actions have been initiated, and you did not provide an expected timeframe for implementation of the corrective actions.
The inspection revealed that your 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 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
• Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm did not have a written Medical Device Reporting procedure for a standardized review process or procedure to determine when an event meets the MDR criteria, or for the documentation of the information that was evaluated to determine if an event was reportable.
We have reviewed your response and have concluded that it is inadequate. Your response said you will correct in a timely manner all observations that the investigator observed during the inspection, including MDR procedures. However, the response did not specify what corrective actions you would take to address the noted violations, you did not include documentation to show that corrective actions have been initiated, and you did not provide an expected timeframe for implementation of the corrective actions.
Our inspection also revealed that these devices are misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. 360; were not included in a list required by section 510(j), 21 U.S.C. 360(j); or notices or other information respecting the device were not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k).
1. Your firm operates as a device manufacturer in that you physically assemble medical devices. However, a review of our records revealed that your firm is registered as a repacker/relabeler. To date, you have not registered your firm as a medical device manufacturer.
2. Our records also revealed that the your firm did not submit device listings for the Nex-Gen Clear Surgical Mask or the Nex-Gen Respirator Mask devices, which are manufactured at your firm. The Nex-Gen Clear Surgical Mask is a Surgical Mask device, Product Code FXX. The Nex-Gen Respirator Mask is a Surgical Respirator device, Product Code MSH. Your firm submitted a device listing for a Breathing Circuit Bacterial Filter, Product Code CAH, which is not a correct listing for the Nex-Gen Clear Surgical Mask or Nex-Gen Respirator Mask devices.
Our inspection also revealed that the Nex-Gen Clear Surgical Masks and Nex-Gen Respirator Masks are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do 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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). These devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your 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 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your devices is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your products may be legally marketed.
1. Specifically, your firm modified a bacterial filter (product code CAH) by combining it with an oxygen mask to create your Nex-Gen Clear Surgical Mask (a class II device, product code FXX). In addition, your firm has changed the indications of use for the bacterial filter. Breathing circuit bacterial filters are intended to remove microbiological and particulate matter from the gases in a breathing circuit. You promote your Nex-Gen Clear Surgical Mask for the following indications:
a. to be used for “infection control practices in the Health Care Industry,”
b. “[f]or use on all human populations to filter respiratory gases where infection from airborne bacteria and viruses is a concern,” and
c. “[t]o protect all from transfer of microorganisms, blood and body fluids.”
2. Additionally, your firm modified the bacterial filter (product code CAH) by combining it with an oxygen mask and other components, to create your Nex-Gen Respirator Mask devices (a class II device, product code MSH). Your Nex-Gen Respirator Masks are intended to be reusable for up to 240 hours.
In addition, the Nex-Gen Respirator Mask is misbranded under 502(b), 21 U.S.C. 352(b), in that the device is in package form and its label fails to specify conspicuously the name and place of business of the manufacturer, packer, or distributor. 21 CFR 801.1.
• Specifically, your Nex-Gen Respirator Mask does not have a label that conspicuously specifies your place of business.
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. Also, federal agencies are advised of the issuance of all 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 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 violations, 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 the Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204, Attention: Shari J. Shambaugh, Director of Compliance Branch. Refer to the Unique Identification number, 2011-DAL-WL-16, when replying. If you have any questions about the content of this letter please contact: Rose Ashley at (210) 541-9450, Ext. 118.
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 (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.
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
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