Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
CMS # 437080
UNITED PARCEL SERVICE
August 18, 2014
Mr. Charles H. Cossman, President,
Simply Clean Air & Water Inc.
28 Shepard Drive
Newington, CT 06111-1158
Dear Mr. Cossman:
The Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operation at Simply Clean Air & Water Inc., 28 Shepard Drive, Newington, CT from July 9 through July 18, 2014. During the inspection, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Portable Exchange Deionization systems (PEDI). 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 to affect the structure or any 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received your response dated August 5, 2014 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. Your firm did not provide any documentation that these items will be addressed swiftly. The violations include, but are not limited to, the following:
1. Failure to establish and maintain design validation procedures to ensure that the device conforms to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions; and to ensure the results of design validation, including the identification of the design, methods, the date, and the individuals performing the validation are documented in the design history file, as required by 21 CFR 820.30(g). For example, your firm’s PEDI systems provide water for hemodialysis applications and are labeled to meet the requirements of an outdated standard, ANSI/AAMI RD62:2001. Your firm did not provide any documentation that your PEDI systems have undergone testing to demonstrate the devices meet the requirements of the current ANSI/AAMI standard, nor has any testing been performed for (b)(4).
Also, your firm does not have any design control procedures to control the design of the device in order to ensure that specified design requirements are met.
2. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a). For example, your firm does not have any inspection, test or acceptance criteria for materials used in the manufacture of your medical devices. We observed that incoming components are placed directly into inventory upon receipt.
3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products conform to specified requirements, as required by 21 CFR 820.50 Your firm does not maintain any supplier qualification forms as required by your own procedure, and could not provide any records of inspection or testing for any incoming materials.
4. Failure to maintain a device history record (DHR) that includes acceptance records which demonstrate that the device is manufactured in accordance with a device master record, as required by 21 CFR 820.184(d). For example, during the inspection, when we requested device history records for Portable Exchange Deionized Water Systems manufactured by your firm, you were only able to provide a packing slip and a worksheet entitled, “Resin Regeneration Data Sheet”. These records were missing acceptance activity data.
We find that your August 5, 2014 response is not adequate to address the above violations. You have indicated that some of these observations will not be completed until January 16, 2015.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 violations 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 notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
We also request that you provide supporting documentation of your promised corrections to the remaining FDA-483 items not described above.
Please send your reply to the Food and Drug Administration, Attention: Karen N. Archdeacon, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-587-7491.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Mutahar S. Shamsi
New England District Office