Inspections, Compliance, Enforcement, and Criminal Investigations
Medical Solutions International, Inc. 30-Apr-08
Department of Health and Human Services
Public Health Service
Kansas City District
April 30, 2008
RETURN RECEIPT REQUESTED
Ref. KAN 2008-06
Jack R. Dillon, President
Medical Solutions International, Inc.
5646 Merriam Dr.
Merriam, KS 66203
Dear Mr. Dillon:
During an inspection of your firm located in Merriam, Kansas on March 5 -17, 2008 an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures BiPro SDS-CB200 Bicarb Mixing and Distribution Systems. 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 are intended to affect the structure or function of the body.
This inspection 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 (CFR), Part 820. These violations include, but are not limited to, the following:
Failure to establish and maintain document control:
• Document control procedures were not established. [21 CFR 820.40]
• Documents that were not approved and obsolete were observed at a location where they are
being used. [21 CFR 820.40(a)]
• Changes to documents were not reviewed and approved by an individual in the same function or organization that performed the original review. [21 CFR 820.40(b)]
Failure to establish and maintain written procedures in the following areas:
• Procedures for identifying training needs for those personnel who manufacture BiPro SDS-CB200
Bicarb Mixing and Distribution System were not established. [21 CFR 820.25(b)]
•Procedures for identifying product throughout all stages of receipt, production, packaging,
distribution, and installation were not established. [21 CFR 820.60]
•Procedures for changes to specifications, processes, and procedures were not established.
[21 CFR 820.70(b)]
• Labeling procedures were not established. [21 CFR 820.120]
• Procedures have not been established to ensure that mix-ups, damage, or other adverse
effects to product do not occur during handling. [21 CFR 820.140]
• Procedures for controlling the storage of product in storage areas and stock rooms were not
established to prevent mix-ups, damage, and other adverse effects. [21 CFR 820.150(a)]
• Procedures for the control and distribution of finished devices have not been established to
ensure that only devices approved for release are distributed. [21 CFR 820.160(a)]
• Installation, inspection, and test procedures have not been established such that the device
will perform as intended after installation. [21 CFR 820.170(a)]
You should take prompt action to correct the violations addressed 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 approval applications for Class III 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.
This letter is not intended to be an all-inclusive list of the violation(s) 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.
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 direct your response to Nadine Nanko Johnson, Compliance Officer, Food and Drug Administration, at the above letterhead address.
John W. Thorsky