Inspections, Compliance, Enforcement, and Criminal Investigations
LSL Industries, Inc. 3/30/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
March 30, 2012
RETURN RECEIPT REQUESTED
LSL Industries, Inc.
5535 North Wolcott Avenue
Chicago, IL 60640
Dear Mr. Luthra:
During an inspection of your firm located in Chicago, IL, from January 31 through February 24, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and repacks Class I and Class II sterile disposable devices including: urinary drainage bags, catheterization sets, IV start kits and Laceration trays. 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 maintain process validation where the results of the process cannot be fully verified by subsequent inspection and test. The validation process must be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the dated signature of the individual approving the validation, must be documented to comply with 21 CFR 820.75(a). This applies, where appropriate, to major processing equipment that must be validated.
Your firm failed to follow your document # 01-07 “Packaging Validation Protocol”. In that document one of your (b)(4) units identified product 1616 (Cauterization Pack, Urethral) as being selected for validation as the product with the worst-case scenario for packaging. Your document # 01-07 Packaging Validation Protocol (activity logs), indicates product 1450VA (Drainage Bags) was utilized for validation activities. Your summary report does not provide justification for the substitution of product 1616 for product 1450VA. In addition, in the final report, it states that rejected seals were to be documented and retained for QC review. Your firm could not provide any documentation showing that rejected seals were identified during this packaging validation and there were no rejection parameters defined as part of this 01-07 protocol. Your firm owns (b)(4) separate (b)(4) machines used to seal the following products: Central Line Dressing Trays, Premium Irrigation Trays, Laceration Trays, Foley Catheterization Trays and Skin Scrub Trays. The raw data indicates that your firm only validated (b)(4) of your (b)(4) machines, specifically (b)(4).
You use “Packaging Validation Protocol 01-04”, for the (b)(4) Machine for the Tyvek lidded flexible pouches for (b)(4) sterilization devices. No explanation was given as to why an IV start Kit was chosen as the worst case among the various products packaged on this form-fill seal machine unit.
You use your (b)(4) for Tyvek lidded semi-rigid trays for (b)(4) sterilized devices. No explanation was given as to why the catheterization tray with a prefilled syringe, product code 1505, was chosen as the worst case from among the various products packaged using this (b)(4) machine.
Your firm failed to follow warnings listed on letters from your three suppliers of single lumen hypodermic needles. These letters state that you are responsible for qualifying product compatibility with the needles’ sterilization cycles. Your firm manufactures several kits that utilized (b)(4) or (b)(4) sterilized single lumen hypodermic needles as a component part of kits. You have not qualified the sterilization process to ensure that (b)(4) sterilization of the kits does not adversely affect these pre-sterilized single lumen hypodermic needles.
2. Failure to document when changes or process deviations occur. You must review and evaluate the process and perform revalidation where appropriate. These activities must be documented to comply with 21 CFR 820.75(c).
Your firm failed to re-validate after your QA/RA department’s notification letters were issued on 11/07/2011 and 11/30/2011. These letters stated that due to changes in the heating elements for each of the (b)(4) machines, the sealing temperature parameters for each of the (b)(4) machines are to be changed. Only (b)(4) machines’ heating elements were changed out of the (b)(4) machines. Your firm failed to performed a re-validation study for the revised heat-sealing parameters of those (b)(4) units. Your firm could not provide justification for the revised heat-sealing parameters for the remaining (b)(4) machines, which were not affected by replacement of their heating elements.
3. Failure to control nonconforming product. Each manufacturer must establish and maintain procedures to control product that does not conform to specified requirements. The procedures must address the identification, documentation, evaluation, segregation, and disposition of the nonconforming product. The evaluation of nonconformance must include a determination of the need for an investigation and notification of the persons or organization responsible for the nonconformance. The evaluation and any investigation must be documented as required by 21 CFR 820.90(a).
Your firm failed to control non-conforming product. During the period of January 1, 2011 through December 31, 2011 your firm identified the following nonconformances: (b)(4) bad seals, (b)(4) missing components, (b)(4) wrong components, (b)(4) dirty components, (b)(4) extra components, and (b)(4) component defects. We were informed that the above nonconformities were initially documented on your “Product Nonconformity Report”. That report had documented the following information: item number, specification, Quantity Rejected, Date/Time, and lot number. That report failed to document product disposition and documentation of the close-out for the above nonconformities.
4. Failure to establish and maintain procedures for implementing corrective and preventive actions as required by 21 CFR 820.100(a)
Your firm failed to follow your “Corrective and Preventive Action” (b)(4) procedures after nonconformities were identified. Your Quality person performs a check on each kit manufactured on the line up until the discovery of the initial nonconformity. This check is not performed in accordance your documented SOP in your “Corrective and Preventive Action” (b)(4). If additional nonconformities were discovered during re-inspection of manufactured product, additional documentation was not completed and a total count of all nonconformities discovered during re-inspection were not documented.
5. Failure to establish and maintain procedures for acceptance activities. Each manufacturer must document acceptance activities required by this part. These records must include acceptance activities performed, the dates acceptance activities performed, the results, the signatures of the individuals conducting the acceptance activities and where appropriate the equipment used. These records must be part of the Device History Record (DHR), as required by 21 CFR 820.80(e)
Quality inspections are not performed on incoming medical device components. Quality Assurance personnel perform a post-inspection sampling of all products manufactured prior to release for sterilization. The acceptance activities performed are not specified, and the results of the post-production/pre-sterilization inspection sampling are not documented.
6. Failure to have and maintain Device History Records (DHR’s). Each manufacturer must establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR) and its requirements. The DHR must include, or refer to the location of the following: date of manufacture, quantity manufactured, quantity released for distribution, the acceptance records to show that the device is manufactured in accordance with the DMR, the primary identification label and labeling used for each production unit, and any device identification and control numbers, as required by 21 CFR 820.184.
Your firm failed to include in your DHR the following: incoming component inspection and post-production/pre-sterilization inspection sampling. Your firm cannot determine the amount of product manufactured or the quantity of the product distributed, which precludes reconciliation of the product manufactured and reconciliation of product labeling.
We have reviewed your responses letters, dated March 8 and 16, 2012, and concluded that the adequacy of your response cannot be determined at this time since supporting documentation of the corrective actions was not provided. You stated in your response letter dated March 18, 2012, that your proposed corrective actions are planned for completion on or before September 30, 2012.
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.
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.
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 Form FDA 483, Inspectional Observations, 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.
Your firm’s response should be sent to the Chicago District Office, Compliance Branch. If you have any questions about the contents of this letter, please contact: Matthew Sienko, Compliance Officer at (312) 596-4213 or e-mail firstname.lastname@example.org
Scott J. McIntire