| Public Health Service Food and Drug Administration |
Cincinnati District Office |
Department of Health and Human ServicesOctober 12, 2011
VIA United Parcel Services
WARNING LETTER
CIN-12-232214-01
Frank Guidone
CEO
Measurement Specialties, Inc.
1000 Lucas Way
Hampton, VA 23666
Dear Mr. Guidone:
During an inspection of your firm located at 2670 Indian Ripple Road, Dayton, OH 45440 on May 17, 2011 through July 25, 2011, investigators from the United States Food and Drug Administration ("FDA") determined that your firm is the manufacturer of temperature probes for pediatric and adult use. 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.
This inspection revealed that the medical 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 manufacturing, 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. We received your response dated August 15, 2011 to our investigators’ observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address your response below, as it relates to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to implement and maintain adequate procedures for implementing corrective and preventive action that shall include analyzing processes, work operations, concessions, audit reports, quality reports, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming products, or other quality problems, as required by 21 C.F.R. § 820.100(a)(1).
Your SOP 020 Corrective Action Procedure, dated 01/06/2011 does not adequately address the statistical methods that will be utilized to analyze quality data to identify existing and potential causes of nonconforming product or other quality problems.
Specifically, your firm is not analyzing nonconformances found during finished device assembly based on a statistical methodology that will detect recurring quality problems. A total of 9 of the 11 device history record reviewed had the reasons for the nonconformances during finished device assembly that were dispositioned as scrap recorded, but this data is not being analyzed based on a statistical methodology to detect recurring problems. Additionally, your analysis of scrap is only performed on “total dollar value of scrap for all products”, which includes medical, aerospace and industrial.
Your response states that by September 1, 2011 you will establish procedures for analyzing and documenting scrap, and for determining when a corrective action should be taken in regards to scrap. Please provide a copy of your new procedures and any other supporting records, so we can assess these corrective actions.
2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR§ 820.90(a).
Specifically, your SOP 083 Mfg: Control of Nonconforming Product procedure, dated 10/2/2009, is not adequate in that:
a) The procedure states “The separated nonconforming product is identified with a red tag, Placed in a red container or marked such that its status is clearly identified for later disposition of disposal as solid waste.” On 6/2/2011, FDA investigators observed an assembler of a general purpose probe, set a probe aside and went on break. Another assembler, working in that area, picked up the probe, packaged and sealed it. Discussion with the assembler, who set the probe aside, revealed the probe was nonconforming because it contained abnormal “little ink”. The assembler did not follow your procedure of identifying the nonconformance with a red tag. As a result the probe was packaged and sent for sterilization.
b) The procedure states that “For medical products, the number of in-process adjustments is limited and is defined within the work instructions.” A total of 4 of the 11 work instructions reviewed allow for in-process adjustments, but the number of in-process adjustments is not defined in the work instructions.
Your response to this observation can not be assessed at this time. Your response lists several timeframes and dates for revising procedures, training employees, updating the device history record work instruction page, and reviewing all procedures to ensure that adequate instructions exist to carry out the requirements stated in each procedure. Please provide the revised procedures and documentation that all of these corrective actions have been completed. If they are still in-progress, please provide an update on the status of these corrective actions.
3. Failure to establish and maintain procedures for rework, to include retest and reevaluation of nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR§ 820.90(b)(2).
Specifically, the rework and in-process adjustments requirements listed in the individual work instructions for medical temperature probes are not being followed. For example, on May 25, 2011, the FDA investigators observed a manufacturing employee rework 4 temperature probes from lot 11E51809 for failing their resistance tests. The employee did not follow the directions listed in the SP20351-3 work instruction for “in-process adjustments”, in that the directions on how to perform the adjustments were not followed and the rework was not documented in the device history record.
Your response to this observation can not be assessed at this time. Your response states you will revise your device history record (DHR) procedures by September 23, 2011; and will revise the DHR page of all medical product work instructions to include the same rework requirements contained on your revised procedures by November 29, 2011. Please provide any revised procedures and documentation that have been completed. For corrective actions still in-progress, please provide an update on their status.
4. Failure to establish and maintain procedures for identifying valid and statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics, as required by 21 CFR§ 820.250.
Specifically, there is no statistical methodology used for establishing the acceptable alert levels listed in the work instructions for the temperature probes. For example, the SP21470-409AC work instruction states under Op 50 “If more than 10% of the probes are out of specification, contact Manufacturing Engineer for troubleshooting and corrective action.” There is no statistical basis for setting the alert level at 10% for failures that occur during this operation.
Your response did not address this observation.
5. Failure to verify, or where appropriate validate according to § 820.75, changes to a specification, method, process, or procedure, as required by 21 CFR § 820.70(b).
Specifically, the changes to the manufacturing process of several temperature probes, which includes changes to the tip cleaning process, under Document Change Notice #DCO-001466, were not verified or validated.
Your response to this observation can not be assessed at this time. Your response lists several timeframes and dates for revising design change procedure, your document change form, training employees, and reviewing all waivers. Please provide the revised procedures and documentation that all of these corrective actions have been completed. If they are still in-progress, please provide an update on the status of these corrective actions.
6. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR § 820.80(b).
Specifically, your SOP 154 Receiving Inspection procedure, dated 10/11/2010 does not contain clear definitions and instructions to ensure the employee chooses the correct inspection level for determining the number of samples to pull for acceptance activities for incoming components.
For example, an employee performed a General Inspection Level II AQL 1.0 sampling for inspection of incoming thermistors, which are components of airway temperature probes. According to your procedures a Level II inspection, which is defined as 100% inspection, should have been performed.
Your response to this observation can not be assessed at this time. Your response states that the receiving inspection procedures will be revised by September 9, 2011, and will retrain employees on this procedure by September 12, 2011. Please provide copies of the revised procedures and documentation that this corrective action has been completed.
7. Failure to establish procedures for identifying training needs and ensure all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR § 820.25(b).
Specifically, the site manager has been acting Quality/Regulatory Manager since April of 2011 and has not received training to perform his assigned responsibilities.
Your response to this observation can not be assessed at this time. Your response lists several timeframes and dates for revising procedures; identifying and defining skill levels for “critical positions”; requiring the qualification for temporary replacement personnel; conducting ongoing training; and implementing a new training and evaluation program. Please provide the revised procedures and documentation for the corrective actions that have been completed. If they are still in-progress, please provide an update on the status of these corrective actions.
8. Failure to assure quality audits are conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR § 820.22. Specifically, your Quality/Regulatory Manager audited areas for which he is directly responsible.
Your response to this observation can not be assessed at this time. Your response states that the audit procedure will be reviewed and revised by October 21, 2011. Please provide a copy of this procedure when the revision is completed.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in the initiation of regulatory action without further notice. This may include, but is 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 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.
Please notify this office 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 actions you have taken. If your planned corrective actions 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.
Your response should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 2167, or you may forward a facsimile to her at (513) 679-2773.
Finally, you should know that this letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by the FDA. The specific violations noted in this letter and in the FDA 483s 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 action to correct the violations and to bring your products into compliance.
Sincerely,
/s/
Jane M. Kreis
Acting District Director
Cincinnati District
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