Inspections, Compliance, Enforcement, and Criminal Investigations
Les Laboratoires Blanchard 12/23/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
DEC 23 2011
VIA UNITED PARCEL SERVICE
Mr. Jean Blanchard
Co-owner and President
Les Laboratoires Blanchard
1552 King Ouest, Suite 200
Dear Mr. Blanchard:
During an inspection of your firm located in Sherbrooke, Quebec, Canada on August 29, 2011, through September 01, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures contact lenses. 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 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
Your firm’s responses to the Form FDA 483 (FDA 483) dated September 22, 2011, and November 25, 2011 were not reviewed because they were not received within fifteen business days of issuance. The responses may be evaluated along with any other written material provided in response to the -violation cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:
a. Your firm’s procedure, Action Corrective & Preventive/Corrective & Preventive Action”, P10, version 04, dated February 25, 2011, states that efficiency [effectiveness] evaluation should be conducted and recorded in Form 10-01, DACP-CAPA, version 4, (b)(4)
However, DACP-CAPA, Form 10-01, numbers 2011-05, 2011-03, 11-001, 2011-06 and 10-007 documented the implementation date of the corrective action, but did not document, in Section C, whether the corrective action/preventive actions were effective in correcting or preventing reoccurrence or whether the actions taken adversely affected the product.
b. Your firm’s procedure, “Action Corrective & Preventive/Corrective & Preventive Action,” P10, version 04, dated February 25, 2011, states that validation should be performed to evaluate the efficiency [effectiveness] of the implemented actions and to prevent the event from recurring. DACP-CAPA, Form 10-01, number 11-005, was opened due to (b)(4). However, the corrective and preventive actions implemented in CAPA 11-005 were not verified and validated to ensure the actions were effective and did not adversely affect the product.
2. Failure to document the monitoring and control methods and data, the date performed, and where appropriate, the individual(s) performing the process or the major equipment used, as required by 21 CFR 820.75(b)(2). For example:
a. Your firm, as part of the monitoring and control of its autoclave sterilization process, records in Form F05-01, version 1, (b)(4) the readings of (b)(4) However, the identification of the (b)(4) used for each run is not documented in the sterilization lot record or the Device History Records for the products.
b. During the sterilization process, (b)(4) are used to monitor the cycle parameters during each production run cycle. However, no documentation of the individual (b)(4) identification numbers was retained in processing records or in sterilization lot records. In addition, no documentation of the (b)(4) identification numbers are maintained as part of the (b)(4) maintenance records when (b)(4) are replaced.
3. Failure to review and evaluate the process for changes or process deviations and perform revalidation where appropriate, as required by 21 CFR 820.75(c). For example:
a. Your firm’s DACP-CAPA No. 2011-05, was opened on June 22, 2011, due to the failure to conduct a (b)(4). The corrective action was to perform a (b)(4) testing (4 cycles), which analyzes the locations most difficult (b)(4). However, the results of the most recent (b)(4) validation testing were not evaluated, documented and utilized by your firm to determine placement of the (b)(4) to ensure the identified (b)(4) were monitored as part of each production run.
b. Your firm’s nonconformance records, Rapport d’événement-Event Report No. 11-29, dated July 6, 2011; No. 11-30, dated July 21, 2011; No. 10-24, dated October, 01, 2010; and Form F11-01 version 1, (b)(4) states that (b)(4) were replaced in (b)(4) due to various reasons. In addition, nonconformance record, Rapport d’événement-Event Report No. 10-002, dated January 06, 2010, stated that a (b)(4) was replaced on (b)(4) However, no documentation of reviews, evaluations, or revalidations for (b)(4) was available after changing (b)(4).
4. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198.
For example, your firm’s complaint handling procedure, (b)(4) 109-02, version 01, dated February 22, 2011, and your firm’s (b)(4) P09, version 5, dated February 25, 2011, lacked the following:
a. Ensure that each and every complaint received is documented upon receipt.
b. Ensure that all complaints are reviewed and evaluated to determine whether an investigation is necessary.
c. Ensure that if no investigation is conducted, the rationale and signature of the person making the determination is documented.
d. Ensure that when an investigation is conducted, the date of the complaint received is recorded and the dates and results of investigations are documented and retained as part of the complaint files.
e. Ensure that replies to the complainant are retained in the complaint records.
5. Failure to adequately ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a).
For example, your firm’s nonconformance report, Rapport d’événement-Event Report No.: 11-029, dated July 06, 2011, involved the replacing (b)(4) because of erratic readings during cycle run #5569. Also, Rapport d’événement-Event Report No: 11-30, dated July 21, 2011, involved the (b)(4) because of erratic readings during cycle run #5581. In addition, Rapport d’événement-Event Report No.: 11-24, dated October 01, 2010, involved the replacement of (b)(4) Finally, Rapport d’événement-Event Report No.: 10-002, dated January 06, 2010, involved the replacement of (b)(4) because it was defective during run #2527. However, no documentation was available for the calibration status of the defective and new (b)(4) prior to use in production.
6. Failure to document calibration procedures to include specific directions and limits for accuracy and precision, and provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality, as required by 21 CFR 820.72(b).
For example, your firm’s calibration record, “Rapport D’étalonnage,” dated April 05, 2011, states that the (b)(4) located at the (b)(4) position for (b)(4) was noted to be out-of-calibration. However, no documentation of an evaluation or of any remedial actions taken was available.
7. Failure to establish and maintain adequate procedures for changes to a specification, method, process or procedure, as required by 21 CFR 820.70(b).
For example, your firm’s calibration/maintenance schedule calendar, (b)(4). However, no production and process changes procedures have been established for the sterilization process in order to identify when changes made to the (b)(4) require verification, and where appropriate, validation or re-validation.
8. Failure to establish adequate procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.
For example, your firm’s quality audit procedure, (b)(4) requires audits to be completed a minimum of once per year per process. However, no audits were conducted in 2009 and between October 2008 and June 2010 for the Ressources area (human resources, calibration, and maintenance of equipment).
Our inspection also revealed that the Les Laboratoires Blanchard Esstech soft contact lenses for daily wear devices are misbranded under section 502(t)(2) of the Act 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1. Failure to develop, maintain and implement an MDR Procedure, as required by 21 CFR 803.17 as exhibited by:
a. Your firm’s MDR procedure fails to establish internal systems that provide for a standardized review process or instructions for:
• Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
• A standardized review process or procedures for determining when an event meets the criteria for reporting; and
• Timely submission of complete medical device reports.
b. Your firm’s MDR procedure fails to describe how your firm will address documentation and record-keeping requirements for:
• Information that was evaluated to determine if an event was reportable; and
• Systems that ensure access to information that facilitates timely follow up and inspection by authorized FDA personnel.
2. Your firm’s MDR procedure fails to describe how your firm will establish and maintain MDR event files as required by 21 CFR 803.18
If your firm wishes to submit MDR reports via electronic submission you can follow the directions stated at the following URL:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, you may contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@fda.hhs.gov.
U.S. 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 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 in writing within fifteen 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 action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.
Your firm’s response should be sent to Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 249294 when replying. If you have any questions about the contents of this letter, please contact: Ronald L. Swann, Branch Chief, Dental, ENT, and Ophthalmic Device Branch at 301-796-5770, or firstname.lastname@example.org.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, FDA 483, issued at the close of the inspection 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 actions to correct the violations and to bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Device and
Mr. Pierre L. Blanchard, Co-Owner
Les Laboratoires Blanchard
1552 King Ouest, Suite 200