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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Asept Pak Inc. 8/7/12


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

Public Health Service
Food and Drug Administration
New York District                
158-15 Liberty Avenue
Jamaica, NY 11433-1034


August 7, 2012
Gary L. Hanley, President and CEO
Asept Pak Inc.
64 West Street
Malone, New York 12953-1118
Dear Dr. Hanley:
During an inspection of your firm located in Malone, New York on June 11 through 20, 2012,  investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Sterile Sodium Chloride 0.9% USP for wound irrigation, and Sterile Sodium Chloride 0.9% for device irrigation.  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 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.  These violations include, but are not limited to, the following:
1)    Failure to adequately document corrective and preventive action activities and results, as required by 21 CFR 820.100(b).  For example, Sterile Sodium Chloride 0.9% USP for wound irrigation, Lot ANR, Batch F11110 was manufactured on August 17, 2011 and released on March 26, 2012.  On August 31, 2012, your contract laboratory reported findings of the microorganism Bacillus clausii, a retest was conducted by the same laboratory on September 30, 2011, which provided sterile results.  Prior to release a second contract laboratory tested the same lot/batch and provided sterile test results.  You have failed to initiate, conduct, and document any investigation in response to the microorganism (a non conformance) found in the initial sample results including, but not limited to, disposition, root cause, and any corrective and preventative action.
2)    Failure to include the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation, in the Design History File (DHF), as required by 21 CFR 820.30(g).  For example, the design history file for Sterile Sodium Chloride 0.9% for wound irrigation has no documentation to demonstrate that design validation was performed and procedures were followed for design validation including, actual or simulated use conditions, and assurances that the device conforms to define user needs and intended use. The Sterile Sodium Chloride 0.9% for wound irrigation was initially produced in May 2011. The initial batches of Sterile Sodium Chloride 0.9% for wound irrigation under your brand name were produced in May 2012 (batches F12117, F12118).
3)    Failure to document process validation activities, as required by 21 CFR 820.75(a).  For example:
a) Your procedure for validation/qualification of processes, software, and equipment indicated the minimum requirements for equipment and utilities are installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).  You failed to document appropriate equipment qualifications (i.e. IQ and OQ) on compounding tanks prior to executing process and product specific performance qualifications. During processing devices such as Sterile Sodium Chloride 0.9%, USP and Sterile Water, USP both for wound irrigation various compounding tanks can be used.  For example, your validation for Sterile Sodium Chloride 0.9%, USP (b)(4) used only the (b)(4)L compounding tank, and lot/batch number ANR/F11110 used the (b)(4)L compounding tank.  We note that two of your  compounding tanks use air sparging and one compounding tank uses an agitator for compounding the Sodium Chloride 0.9% USP. Additionally, each of the three compounding tanks holds a different volume; and
b) Your procedure for validation/qualification of processes, software, and equipment requires that processes are controlled and monitored to ensure that the specified conditions continue to be met.  You failed to define and document the monitoring and control method for your in-process controls associated with the BFS manufacturing process to ensure the specified requirements continue to be met. These include, but not limited to, the  BFS major system components (resin hopper, molds, vacuum system, hydraulic system, filling system, parison air support, fill nozzles system environment, parison knife, and programmable logic controller), and fill volume accuracy control.
4)    Failure to establish and maintain a Design History File (DHF) for each type of device, which shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan, as required by 21 CFR 820.30(j).   For example, you failed to follow your design control procedures prior to manufacturing and distributing SterRx Sodium Chloride 0.9% for device irrigation including batches F10042 and F10043.  Your DHF is inadequate because it fails to include the design concept document, design project plan, design reviews, design validation, and design verification.
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 (including any systemic corrective actions) 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.
Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202.  Refer to Warning Letter NYK-2012-23 when replying. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 541-0324 or E-mail at dean.rugnetta@fda.hhs.gov.
We acknowledge, as indicated during our inspection of your facility, that your firm has stopped manufacturing and distributing drug products.
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. 
Sincerely yours,
Ronald M. Pace
New York District
District Director