Primary Care Solutions, Zephyrhills, FL, Oct. 24 (Florida).

After an Aug. 22-29 inspection, FDA determined that Primary Care Solutions--a manufacturer and distributor of sterile water and saline in bottles, cups and sterile pre-filled inflation syringes used for irrigation and suctioning of medical devices--was not in conformance with the QS regulation.

Violations included that the firm failed to validate devices with a high degree of assurance when the process could not be fully verified by subsequent inspections and tests.

For example, Primary Care failed to complete validation to assure devices could withstand repeated ethylene oxide sterilization cycles; failed to validate the delivery system for sterile water/saline to assure it could deliver the product consistently per specified requirements; and failed to complete the bioburden recovery efficiency test as part of sterilization validation.

Additionally, validation performed in December 2001 for Foil Pack Sealing was inadequately run for 62 samples.

Furthermore, the firm failed to verify or validate CAPA necessary to ensure that such actions were effective and did not adversely affect the finished de vices; failed to establish and maintain requirements that must be met by suppliers; and failed to document the date and results of complaint investigations, such as, documenting the number of defective or allegedly defective units as part of an investigation of consumer complaints.

Complaints not adequately verified or validated included four complaints of breaking syringe flanges; 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; five complaints referencing over-aggressive seals /peel tabs ripping off from the containers; and tip caps missing from pre-filled syringes because of loosening during shipment.

FDA also noted the firm's procedures to control the design processes of devices to ensure that specified design requirements were met, as required, were inadequate.

The company failed to include risk analysis in completing design validation; and the firm's Design History File (DHF) did not 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.

For example, the DHF for the Pre- Filled Inflation Syringe was deficient in the following ways: design validation was not conducted; the DHF failed to contain design verification to assure that syringes and packaging could withstand repeated sterilizations; design verification of tip integrity (Bell Jar Testing) was not documented; and management failed to document the approval of design input.

The DHF also neglected to document changes to the design of the flange and packaging for cups, bottles, and syringes when design changes were made.

Lastly, the firm also failed to develop, maintain and implement written MDR procedures. CAPA, C-H, Design, MDR, QC/QS, Stab, Ster, Val; Doc. 13678W

Primary Care Solutions:

Failed to complete validation to assure devices could withstand repeated ethylene oxide sterilization cycles.

Failed to complete the bioburden recovery efficiency tests.

Neglected to validate CAPA.

Neglected to document results of complaint investigations.

Failed to conduct design validation.

Failed to develop, maintain and implement written MDR procedures.