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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Primary Care Solutions, Inc. 24-Oct-05

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

Public Health Service
Food and Drug Administration


555 Winderley PI., Ste. 200
Maitland, FL 32751




October 24, 2005

Stephen B . Harrington, III, President
Primary Care Solutions, Inc.
40420 Free Fall Avenue
Zephyrhills, FL 33542-5838

Dear Mr. Harrington:

During an inspection of your establishment located in Zephyrhills, Florida on August 22 - 29, 2005, an FDA investigator determined that your establishment is a manufacturer and distributor of sterile water and saline in bottles and cups and sterile pre-filled inflation syringes (Class 11) used for irrigation and suctioning of medical devices. These are devices, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h).

The investigator documented significant violations from the Quality System (QS) Regulation, Title 21, Code of Federal Regulations (CFR), Part 820, and the Medical Device Reporting regulations, 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 Act requires that manufacturers conform to the Quality System (QS) Regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820 and Medical Device Reporting, as specified in Title 21, Code of Federal Regulations (CFR), Part 803.

Quality System Regulation

The investigator noted the following violations of the QS regulation:

1. Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance, approved according to established procedures and documented, as required by 21 CFR 820.75(a). Your firm failed to adequately validate the following processes: (a) The Foil Pack Sealing validation performed in December 2001 was inadequate because the performance qualification consisted of 62 samples that were run at the nominal setting of 555 F in one run; (b) your firm failed to complete validation to assure devices can withstand repeated EO (ethylene oxide) sterilization cycles as promoted in your marketing brochure; (c) your firm failed to validate the delivery system for sterile water/saline to assure it can deliver the product consistently per specified requirements; and (d) your firm failed to complete the bioburden recovery efficiency test as part of sterilization validation (FDA 483, Item #1).

2. Your firm failed to verify or validate the corrective and preventive actions necessary to ensure that such actions are effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). The following are corrective or preventive actions that were not adequately verified or validated: (a) Four complaints received from March 23 - August 17, 2004 referenced breaking syringe flanges. Two preventive actions were taken (1) a change to Besell material in February 2004 and (2) a change to design of flange in November 2004. No verification/ validation of effectiveness was conducted prior to implementation of changes; (b) A complaint #CC04-05 dated September 8, 2004, referenced leakage from a sterile water 30 cc syringe when being used to inflate a 50 cc Foley catheter, which resulted in the incomplete inflation of the catheter. The grommet hardness was changed as a preventive action, but the verification/validation was not documented; (c) Five complaints received from February 7, 2003 - April 1, 2005 referenced over aggressive seals/peel tabs ripping off from the container. Two preventive actions were implemented: (1) in April 2003, your firm changed to a more radiation resistant material; and (2) in 2005, a new procedure was changed to replace torque discs on the capper when aggressive seals were found. These changes were not verified/validated prior to implementation to ensure they were effective; and (4) Complaint #C03- 002 dated March 12, 2003, which referenced two tip caps missing from pre-filled syringes because of loosening during shipment. Preventive action was taken to change the packaging configuration, but verification/validation was not documented to ensure the changes were effective prior to implantation (FDA 483, Item #5).

3. Your firm failed to document the date and results of complaint investigations, as required by 21 CFR 820.198(e)(6). Your firm failed to document the number of defective or allegedly defective units as part of an investigation of consumer complaints (FDA 483, Item #8).

4. Your firm failed to establish and maintain the requirements, including quality requirements, that must be met by suppliers, as required by 21 CFR 820.50(a). Your firm's purchasing controls are inadequate as follows: (a) verification of Certificates of Conformance is not required, (b) your questionnaire and audit criteria for supplier audits fail to include the requirement that suppliers have assured they have adequate process validation for critical processes such as injection molding, (c) your procedures require that suppliers return completed questionnaires every two years; however, most of your suppliers have not returned their completed questionnaires, and (d) checks of new Bisell material including visual and physical, i.e., manually stressing of flanges, were not documented (FDA 483, Item #4).

5. Your firm failed to establish and maintain procedures to control the design processes of device(s) in order to ensure that specified design requirements were met, as required by 21 CFR 820.30(a). Your Design Control procedures fail to include the following: (a) the design of packaging and labeling, (b) a definition of design verification and validation (your firm's personnel were unaware of the difference in terms), (c) a description of how design changes will be documented, and (d) in the Design and Development Planning section, a requirement to identify the group or individual(s) responsible for each part of the project and/or the time schedule when project goals are to be completed (FDA 483, Item #6).

6. Your firm failed to include risk analysis in completing design validation, as required by 21 CFR 820.30(g). Your firm failed to conduct risk analysis for the Pre-filled Inflation Syringe as follows: (a) the risk of the tip coming off the syringe; (b) the risk of the syringe not being able to deliver the intended volume of fluid to inflate Foley Catheter balloons including the causes, the likelihood of this occurring, and the severity of the effect on patients was not documented in risk analysis, (c) the risk of the syringe packaging not being able to withstand repeated sterilization cycles (Gamma, EO, etc.), (d) process validation of the packaging system was not addressed to mitigate the risk of compromising the sterility of the product, and (e) your firm failed to check the MedWatch events system to determine potential risks related to similar products already on the market (FDA 483, Item #2).

7. Your firm's Design History File (DHF) fails to contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of 21 CFR Part 820, as required by 21 CFR 820.30(j). The DHF for the Pre- Filled Inflation Syringe was deficient in the following ways: (a) design validation was not conducted, (b) it fails to contain design verification to assure that syringes and packaging can withstand repeated sterilizations, (c) design verification of tip integrity (Bell Jar Testing) required by Design Review dated April 9, 2003, was not documented, and (d) Executive management failed to document the approval of design input. The DHF also fails to document changes to the design of the flange and packaging for cups, bottles, and syringes when design changes are made (FDA 483, Item #3).

8. Your firm failed to establish and maintain a maintenance procedure until April 2005, and scheduled maintenance is not documented, as required by 21 CFR 820.70(g)(1). As noted above, maintenance procedures were not established until April 2005, and scheduled maintenance to replace front and rear discs on the capping machine manufactured by SUREKAP recommends that discs be changed in pairs because replacements may be of different sizes and that they may wear differently. This maintenance is not documented to ensure that it is done (FDA 483, Item #7).


9. Your firm failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17 (FDA 483, Item #9).

This letter is not intended to be an 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 Singleton
Director, Florida District