Inspections, Compliance, Enforcement, and Criminal Investigations
Prosec Protection Systems, Inc. 2/28/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Waterview Corporate Center
Telephone (973) 331-4900
February 28, 2012
VIA UNITED PARCEL SERVICE
Prosec Protection Systems, Inc.
1985 Swarthmore A venue, Suite 7
Lakewood, NJ 08701-4554
Dear Mr. Kosloski:
During an inspection of your firm located in Lakewood, New Jersey on December 2, 2011 through December 22,2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the My Child Identification Kit. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
The inspection revealed that this device is 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, its manufacture, packing, storage, or installation is 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 establish finished device acceptance procedures, as required by 21 CFR 820.80(d). For example:
A) The standard operating procedure, Sterility Testing, A-116, dated 07/14/10, Section 3.5, states that the only immediate release of products are as follows: (b)(4)
(b)(4) with the BI indicators and (b)(4) after (b)(4) with the (b)(4) Biological Indicators. However, no pass/fail results were recorded for the 12 and 24 hour incubation time check box on the sterilization records dated 09/30/11, 10/11/11, and 10/27111.
B) The standard operating procedure, Review of Sterility Cycle Results, Q213, dated 07/07/10, Section 3.5, states that "regardless of whether the cycle has passed or failed, sign the report on the last page under PROCESS COMPLETE, Approved by." However, sterilization cycle reports, numbers 7389, 7437, 7889, and 7904 were not signed on the Process Complete section. Additionally, the procedure "Review of Sterility Cycle Report," Section 126.96.36.199, describes the System Data Parameters that need to be verified on the cycle reports. However, the parameters present in the procedure do not match the sterilization parameters outlined in sterilization cycle report numbers 7389, 7437, 7889, and 7904.
2. Failure to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures, as required by 21 CFR 820.75(a). For example:
A) The standard operating procedure, Process Validation, SOP 024, dated 07/27/2009, Section 3.4, states that the validation protocol will define the acceptance/rejection criteria. In addition, the firm's sterilization validation protocols, Performance Requalification-Microbiological for Kit and Clamp Products in a (b)(4) Sterilizer, Serial (b)(4) for 2010 and 2011 outlines the parameter of the load temperature not to (b)(4). However, the protocols do not outline other critical parameters to be met in the sterilization cycle runs, such as time, temperature, pressure, plasma, and gas concentration.
B) The sterilization validation protocol, Performance Requalification-Microbiological for Kit and Clamp Products in a (b)(4) Sterilizer, (b)(4) for 2010, Section 5.1, requires that in order to qualify a new larger load, the validation should consist of (b)(4). However, Validation Cycles #6855, #6861, and #6862 were not run consecutively in order to qualify a new, higher-count load which is reported in Performance Requalification/Microbiological of (b)(4) for Sterilizer (b)(4) dated 11/22/2010, Final Report. Additionally, one of the interim runs, Cycle #6860, run on 12/01/2010, failed for "temperature out of range" and no investigation or evaluation was provided for the failed interim run.
C) The standard operating procedure, Process Validation, SOP 024, Section 3.3, dated 07/27/2009, states that the process validation committee shall review and approve validation protocols for organization, content, and adequacy prior to beginning validation studies. However, the sterilization validation protocol, Performance Requalification-Microbiological for Kit and Clamp Products in a (b)(4) Sterilizer, Serial (b)(4) for 2010 and 2011 were not signed by the firm's management prior to conducting the validation.
3. Failure to establish procedures for monitoring and control of process parameters for a validated process, as required by 21 CFR 820.75(b). For example:
A) The (b)(4) biological indicator manufacturer's instructions states that a positive growth control should be used in each indicator on a daily basis and examined at regular intervals (i.e. 12, 18, and 24 hours). However, the standard operating procedure, Sterility Testing, A-116, dated 07/14/10 does not include the use of positive growth controls during routine sterilization runs.
B) The (b)(4) biological indicator manufacturer's instructions states that the (b)(4) Biological Indicators should be placed in a horizontal position. However, the standard operating procedure, Operating the (b)(4) Sterilizer, A-114, Section 188.8.131.52, does not specify the placement of the biological indicators in a horizontal position and your firm was observed using biological indicators in a vertical position during validation runs.
4. Failure to establish procedures for corrective and preventive action, as required by 820.100(a). For example:
A) There is no written standard operating procedure for documenting corrective and preventive actions (CAPA) in the (b)(4) system, which is the software system used for documenting CAPA reports.
B) CAPA reports are inadequately documented. Twenty-one (21) CAPAs were documented for 2010 and 2011 with a "resolved" status, however, not all of these CAPAs were closed. Examples include: CAPA Case #CR4-03748-N6W82T, CAPA Case #CR4-03965-7HZOYQ and CAPA Case #CR4-03299-M7TGMB.
C) Management with executive responsibility has not evaluated and investigated each corrective and preventive action, pursuant to the standard operating procedure, CAP A and Complaint Handling, Document Q214, Section 3.3.2, dated 12/20/2009.
5. Failure to establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
For example, the standard operating procedure, Review and Disposition of Non-Conforming Product, Section 3.2, dated 09/29/2010 states that nonconforming materials shall be documented in the (b)(4) System, however, your firm has not documented any nonconformances for 2010 and 2011.
6. Failure to establish an organization structure to ensure that devices are produced in accordance with 21 CFR 820.20(b).
For example, your management representative has not established an adequate organizational structure to ensure that critical aspects of the quality system are performed. Further, your management representative has not established a quality unit where designated employees are responsible for ensuring the quality of your firm's assembly and sterilization processes for infant umbilical clamps.
7. Failure to validate software which is used as part of the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(i).
For example, the (b)(4) System, which is the system in place for documenting non-conformances, and corrective and preventive actions since 2008, has not been validated according to an established protocol. Further, there is no assurance that the system has the capability of storing or saving critical data, such as complaints, CAP A reports, and nonconformances.
8. Failure to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c).
For example, your firm is not adequately reviewing, investigating or documenting consumer complaints received for the My Child Identification Kit. Specifically, your firm received Complaint Case #CR4-06194-YOMCYF on 09/30/2011 regarding several umbilical clamps slipping on umbilical cords. You requested that the clamps be returned on 10/06/2011, however, you have not taken any measures to conduct an investigation to determine root cause and/or MDR reportability.
9. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 820.198(a).
For example, your firm does not have a written standard operating procedure in place for the documentation of complaints in the (b)(4) System, which is the software system used for complaint handling.
10. Failure to document personnel training in order to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).
For example, your firm lacks adequate training documentation for employees who conduct critical such as the employees responsible for the operation of the (b)(4) Sterilizer. Additionally, you have no training records for those employees who handle complaints.
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 firm's response should be sent to: U.S. Food and Drug Administration, 10 Waterview Blvd, 3rd Floor, Parsippany, NJ 07054. If you have any questions about the contents of this letter, please contact Stephanie Durso, Compliance Officer, at 1-973-331-4911 (phone) or 1-973-331-4969 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by the FDA. The specific violation(s)noted in this letter and in the Inspectional Observations, Form 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 to bring the products into compliance.
New Jersey District