Source: https://www.casewatch.net/fdawarning/prod/2009/pressuretech.shtml
Timestamp: 2019-04-23 14:54:42+00:00

Document:
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.

References: § 321
 § 351
 § 360
 § 360
 § 352
 § 360
 § 360