Inspections, Compliance, Enforcement, and Criminal Investigations
Hydropure Systems Inc 04-Feb-04
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
February 4, 2004
Robert V. Price, President
Hydropure Systems, Inc:
3319 Bartlett Boulevard
Orlando, Florida 32811-6428
Dear Mr. Price:
During an inspection of your establishment located in Orlando, Florida on December 9-15, 2003, FDA Investigator Sonia M. Monges determined that your establishment is a manufacturer of water purity systems for hemodialysis, which are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. section 321(h)].
The investigator documented significant violations from the Quality System (QS) Regulations, Title 21, Code of Federal Regulations (CFR), part 820, and the Medical Device Reporting regulations, Title 21, CFR, part 803. These violations cause the devices you manufacture to be adulterated within the meaning of Section 501(h) [21 U.S.C. §351(h)] and misbranded within the meaning of Section 502(t)(2) [21 U.S.C. §352(t)(2)] of the Act.
The investigator noted the following violations of the QS regulations:
1. Your firm failed to establish and implement quality system procedures and instructions as required by 21 CFR 820.20(e). There were no procedures in place to process water purification systems for hemodialysis for management controls, corrective and preventive action (CAPA), production and process controls and non-conforming product (FDA 483, Item #1).
2. Your firm failed to document and implement corrective and preventive actions as required by 21 CFR 820.100(a) and (b). You received a complaint reporting that a total of seven mixed bed DI cylinders (MB-25) were not completely filled when used during hemodialysis and that the treatment could not be concluded. However, there is no documentation regarding the receipt of this complaint or an investigation having been conducted (FDA 483, Item #4).
Your response, received by fax dated January 14, 2004, and submitted by [redacted] is inadequate because it fails to address the complaint listed in the observation and whether an investigation was conducted. The complaint procedure itself appears to be adequate, but there is no evidence that corrective and preventive action was taken to verify or validate that the actions identified in memos from [redacted] are effective and do not adversely affect the finished device.
3. Your firm failed to establish and maintain schedules for the adjustment, cleaning and other maintenance of equipment to ensure, that specifications are met as required by 21 CFR 820.70(g)(1). You have not calibrated the [redacted] used to test conductivity and resistivity during regeneration. The equipment was purchased one year ago and has not been calibrated since the manufacturer calibrated the device on January 1, 1999 (FDA 483, Item #2)
Although the written procedures you have submitted in response to this observation appear to be adequate, your response does not ensure that the procedures have been established and implemented.
4. Your firm failed to establish and maintain procedures to ensure that device history records (DHR's) for each batch or lot are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the QS regulation as required by 21 CFR 820.184. The QC checks for hemodialysis records dated. February 11, 2003, through July 23, 2003, were incomplete. The records failed to include flow rates, rinse time, pre-chlorine, actual value of megohms, technician name, QC hold tag numbers and the reviewer's signature. On July 30, September 22, October 2 & 21, November 4, and December 9, 2003, only the flow rate and rinse times were recorded. No information was reported on August 5 and September 7, 2003. Also, no entries were made in the Regeneration Log for [redacted], Regeneration Log for [redacted] and the QC of [redacted] Mix Bed for lots manufactured after December 11, 2002 through 2003 (FDA 483, Item #3).
5. Your firm failed to establish and maintain device master records (DMR's) that include or refer to the location of all production: and process specifications as required by 21 CFR 820.181(b). The DMR fails to document or refer to any in-process testing required to be performed during the installation, rinse, testing and packaging of the portable exchange deionization cylinders and conductivity during the verification of exhaustion of mixed bed resins (FDA 483, Item #5).
6. Your firm failed to identify, establish and maintain training needs for manufacturing personnel as required by 21 CFR 820.25(b). The service technician and application engineer have not received QS regulation training since they were hired in 2001 and 2002, respectively (FDA 483, Item #7).
Medical Device Reporting (MDR)
Your devices are misbranded within the meaning of section 502(t)(2) in that there was a failure to comply with a requirement prescribed under section 519 of the Act respecting the device as follows:
7. Your firm failed to establish and maintain written MDR procedures as required by 21 CFR 803.17 (FDA 483, Item #6).
Your response, received by fax dated January 14, 2004, and submitted by [redacted] is inadequate to address all of the deficiencies noted at your facility. As noted above, neither your responses to FDA 483, Item # 4(WL, Item #2) - and Item #2(WL, Item-#3) are not adequate. Moreover, your response does not address any other observations listed in the FDA 483.
This letter is not intended to bean all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. 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.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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 penalties. Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably, related will be cleared until the violations have been corrected. Also, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.
Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.
Emma R. Singleton
Director, Florida District