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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pressure-Tech, Inc. 9/4/09

   

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

Public Health Service
Food and Drug Administration
  New York District
158-15 Liberty Ave.
Jamaica, NY 11433

September 4, 2009


WARNING LETTER

 


VIA FEDERAL EXPRESS                                                                      Ref: NYK 2009-16
                      

Mr. Edward Betts
President
Pressure-Tech, Inc.
102 Woodcleft Avenue
Freeport, NY 11520


Dear Mr. Betts:


During an inspection of your firm located in Freeport, New York, from March 24, 2009, through April 2, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of the Flexi-Lite and Ultra-Lite Hyperbaric Chambers, which are portable hyperbaric soft chambers. 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 intended to affect the structure or function of the body.


Our inspection revealed that these devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for investigational device exemptions (IDEs) 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) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 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.


Specifically, you are introducing the Ultra-Lite Hyperbaric Chamber into interstate commerce without a cleared 510(k) or approved PMA or IDE. The Flexi-Lite Hyperbaric Chamber was cleared via K051759 to provide mild hyperbaria for the treatment of Acute Mountain Sickness (AMS) and its associated mild symptoms. Our inspection revealed that the device labeling, including the American Nitrox Divers International Ltd. (ANDI) Hyperbaric Chamber Operator Training & Reference Text (Course specific Flexi-Lite Portable Chamber), describes the following intended uses, which represent a major change or modification in the intended use of the device that requires a new 510(k). 21 C.F.R. 807.81(a)(3)(ii).


• Air or Gas Embolus;
• Decompression Illness;
• Carbon Monoxide poisoning;
• Clostridal Myonecrosis (Gas Gangrene);
• Necrotizing Fasciitis;
• Crush Injury;
• Selected Problem Wounds;
• Compromised Skin Flaps or Grafts;
• Refractory Osteomyelitis;
• Exceptional Anaemia due to Blood Loss;
• Osteoradionecrosis;
• Thermal Burns & Radiation Tissue Damage;
• Diabetic Wounds and Circulatory Efficiency Enhancement;
• Intra-Cranial Abscess;
• Brain Injury and Other Head Trauma;
• Cerebral Palsy; and
• Lyme Disease.


This inspection also 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 dated April 27, 2009, concerning our investigators' observations noted on the Form FDA 483, List of Inspectional Observations, which was issued to you on April 2, 2009. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:


1. Failure to establish and maintain procedures to control the design of the device, as required by 21 C.F.R. 820.30(a). For example, your firm has not established design control procedures.


We have reviewed your firm's response and have concluded that it is inadequate. You indicated that your firm has modified several procedures and has also implemented improved record keeping, tech support records, incoming component tracking, component QA compliance, in-service product tracking procedures, product labeling and more. However, you did not provide details regarding your design control procedures for the Flexi-Lite and Ultra-Lite Hyperbaric Chambers.

2. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 C.F.R. 820.30(i). For example, your firm made version changes to the Flexi-Lite device without approval of the design change before their implementation.


We have reviewed your firm's response and have concluded that it is inadequate. You indicated that your firm has modified several procedures and has also implemented improved record keeping, tech support records, incoming component tracking, component QA compliance, in-service product tracking procedures, product labeling and more. However, you did not provide documentation regarding written procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.


3. Failure to establish and maintain Design History Files (DHF's) for the Flexi-Lite and UltraLite Hyperbaric Chambers that contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of the QS regulations, as required by 21 C.F.R. 820.30(j). For example, your firm's DHF's did not contain test data for the Flexi-Lite and Ultra-Lite hyperbaric chambers that demonstrate how results of testing, such as Drip Test, Mechanical Test, Environmental Testing, Drop Test, Cycle Test, and Catastrophic Failure Test, met established specifications and methods. In addition, the DHF's did not contain or reference a design and development plan, design reviews, design verification, or design transfer.


We have reviewed your firm's response and have concluded that it is inadequate. You indicated that your firm has modified several procedures and has also implemented improved record keeping, tech support records, incoming component tracking, component QA compliance, in-service product tracking procedures, product labeling and more. However, you did not provide documentation regarding your DHF's that contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan design control procedures.


4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, as required by 21 C.F.R. 820.198(a). For example, there were no written complaint procedures to determine when consumer telephone calls that are referred to your staff because they are technical in nature, are complaints. In addition, there were no written complaint procedures to review, evaluate, document, and investigate customer telephone calls that are complaints.


We have reviewed your firm's response and have concluded that it is inadequate. You indicated that your firm has modified several procedures and has also implemented improved record keeping, tech support records, incoming component tracking, component QA compliance, in-service product tracking procedures, product labeling and more. However, you did not provide documentation regarding your written procedures for receiving, reviewing, and evaluating complaints.


5. Failure to establish and maintain procedures for acceptance activities, as required by 21 C.F.R. 820.80. For example, your firm has not established procedures to verify that incoming components, finished devices, and in-process product conform to specified requirements.


We have reviewed your firm's response and have concluded that it is inadequate. You indicated that your firm has modified several procedures and has also implemented improved record keeping, tech support records, incoming component tracking, component QA compliance, in-service product tracking procedures, product labeling and more. However, you did not provide documentation regarding your written procedures for acceptance activities.


6. 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 C.F.R. 820.50. For example, your firm has not established and maintained requirements, including quality requirements, which must be met by your firm's suppliers, contractors, and consultants.


We have reviewed your firm's response and have concluded that it is inadequate. You indicated that your firm has modified several procedures and has also implemented improved record keeping, tech support records, incoming component tracking, component QA compliance, in-service product tracking procedures, product labeling and more. However, you did not provide documentation regarding your written procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.


7. Failure to establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements, as required by 21 C.F.R. 820.200(a). For example, your firm provides servicing that includes disinfection and servicing the chambers under their warranty. Upon completion of servicing or disinfecting the chamber, it is re-pressurized and re-tested prior to returning it to the customer. However, your firm has not established written procedures to verify that the servicing meets the specified requirements.


We have reviewed your firm's response and have concluded that it is inadequate. You indicated that your firm has modified several procedures and has also implemented improved record keeping, tech support records, incoming component tracking, component QA compliance, in-service product tracking procedures, product labeling and more. However, you did not provide documentation regarding your written procedures for performing and verifying that the servicing meets the specified requirements.

8. Failure to maintain device master records (DMR's) for the Flexi-Lite and Ultra-Lite Hyperbaric Chambers that include, or refer to the location of, quality assurance procedures and specifications, as required by 21 C.F.R. 820.181(c). For example, your firm's DMR's do not include, or refer to the location of, quality assurance procedures for assembly and product testing of the Flexi-Lite and Ultra-Lite hyperbaric chambers.


We have reviewed your firm's response and have concluded that it is inadequate. You indicated that your firm has modified several procedures and has also implemented improved record keeping, tech support records, incoming component tracking, component QA compliance, in-service product tracking procedures, product labeling and more. However, you did not provide documentation regarding the maintenance of your DMR's to include or refer to the location of quality assurance procedures and specifications.


9. Failure to establish and maintain procedures to control labeling activities, including labeling and packaging operations to prevent labeling mixups. The label and labeling used for each production unit, lot, or batch shall be documented in the device history record (DHR), as required by 21 C.F.R. 820.120(d). For example, you identify each chamber after manufacture and prior to shipment, with a model, version, and serial number. The model, version, and serial numbers are also identified on the sales order, shipping documentation, and testing records generated after a purchase. There are no written procedures to ensure that the version and serial numbers generated after purchase match the version and serial numbers on the chamber to be shipped.


We have reviewed your firm's response and have concluded that it is inadequate. You indicated that your firm has modified several procedures and has also implemented improved record keeping, tech support records, incoming component tracking, component QA compliance, in-service product tracking procedures, product labeling and more. However, you did not provide documentation regarding your written procedures for control labeling activities.


10. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. In addition, failure to document training, as required by 21 C.F.R. 820.25(b). For example, you state that personnel are required to complete on-the-job training for technicians who assemble and test each hyperbaric chamber. However, there were no written employee training procedures or training records available during the inspection to assure that all personnel are trained to adequately perform their assigned responsibilities.


We have reviewed your firm's response and have concluded that it is inadequate. You indicated that your firm has modified several procedures and has also implemented improved record keeping, tech support records, incoming component tracking, component QA compliance, in-service product tracking procedures, product labeling and more. However, you did not provide documentation regarding your written procedures for identifying training needs, or documentation that all personnel are trained to adequately perform their assigned responsibilities. In addition, you did not provide documentation regarding training for control labeling activities.


Our inspection also revealed that your Flexi-Lite Hyperbaric Chamber and Ultra-Lite Hyperbaric Chamber 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 medical device reporting procedures, as required by 21 C.F.R. 803.17. For example, your firm has not developed and did not furnish written MDR procedures.


We have reviewed your response and conclude that it is inadequate because you did not provide documentation regarding your written medical device reporting procedures.


You should take prompt action to correct the violations addressed above 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 notification applications for Class II 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 (15) 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 15 working days, state the reason for the delay and the time within which the corrections will be completed.


Please send your response to the Food and Drug Administration, Attention Lillian C. Aveta, Compliance Officer, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have any questions about the content of this letter please contact Lillian Aveta at 718-662-5576.


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/
Camille Monde
Acting District Director
New York District


Enclosure: Form FDA 483 dated April 2, 2009