Inspections, Compliance, Enforcement, and Criminal Investigations
Monarch Labs, LLC 11/9/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
November 9, 2010
Dr. Ronald A. Sherman
Monarch Labs, LLC
17875 Sky Park Circle, Suite K,
Irvine, California 92614
Dear Dr. Sherman:
During an inspection of your firm located in Irvine, CA on June 3 through June 14, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures, markets and distributes the Medical Maggots and Maggot Confinement Dressings indicated for debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers and non-healing traumatic or post surgical wounds. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), the Medical Maggots and Maggot Confinement Dressings 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 the device is adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 35l(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. We received responses from you dated July 27 and August 13, 2010 concerning our investigator's observations noted on the Form FDA 483, Inspectional Observations that was issued to you. Your response was not reviewed because it was not received within 15 business days. The response may be evaluated along with any other written material provided in response to this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, your firm uses a (b)(4) autoclave to sterilize device components such as distilled water used to (b)(4) process, Creature Comfort (b)(4) netting dressing, culturing media, sterilized vials used to store eggs, and sterilized (b)(4) media. However, your firm’s process and equipment used in the sterilization and disinfection of fly eggs for use as Medical Maggots were not validated. Additionally, your firm is not conducting a weekly spore testing on the autoclave as per written procedure, WI 0902-08, “Autoclaves & Sterilizers”, Rev A, dated August 1, 2009.
2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action (CAP A) to include requirements for investigating the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2). For example, a review of your CAPA record (CAR# 2010-003) indicated that an investigation was conducted to determine the cause of the nonconformance. The investigation determined that multiple vials of sterilized culture media "growing contaminant" or "poor handling'' may have been the cause of the non-conformance. However, the CAPA did not list which lot of media was used and your firm was unable to determine the root cause of the contamination or provide adequate information regarding the disposition of the non-conforming product.
3. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements to include addressing the identification, documentation, evaluation, segregation and disposition of nonconforming product, as required by 21 CFR 820.90(a). For example, the Standard Operating Procedure (SOP-1301-Policy for Items which Fail Inspection-Rev B), dated September 16, 2009, did not provide enough information as to how to deal with non conforming issues.
4. Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements to include quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). For example:
• Your firm has not established procedures for evaluating and qualifying your suppliers, vendors and contractors.
• Your firm could not provide any documentation to show you established specifications for checking the vials received from your supplier used to package medical maggots.
5. Failure to establish and maintain adequate procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements, as required by 21 CFR 820.80(b). For example:
• Your firm did not inspect incoming materials such as the vials used to package medical maggots.
• Your firm did not document inspection of incoming materials.
6. Failure to 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. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72 (a). For example, your film could not provide documentation showing the (b)(4) incubators were qualified for the equipments' intended functions.
7. Failure to monitor production processes to ensure that a device conforms to its specifications as required by 21 CFR 820.70(a). For example, your firm could not provide documentation showing the autoclave, drying oven, laminar flow hood, and refrigerator used in the manufacture of.your firm's devices were qualified to assure that the equipment will meet your required specifications.
8. Failure to control labeling and packaging operations to prevent labeling mixups and to ensure the label and labeling used for each production unit, lot, or batch is documented in the Device History Records, as required by 21 CFR 820.120(d). For example:
• Your firm does not have any written procedures that control labeling activities.
• Copies of labels that were intended to be affixed to finished products were not kept in the device history record.
9. Failure to establish and maintain procedures to ensure that device history records (DHRs) for .each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR) and the requirements of the Quality System regulation, as required by 21 CFR 820.184. For example, your firm could not produce an SOP outlining how DHRs will be maintained or what types of documents are placed in the DHRs.
10. Failure to establish and maintain adequate procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed and documented, as required by 21 CFR 820.250(b). For example, your firm stated that you perform inspections of incoming raw materials in accordance with the (b)(4) statistical method; however, you did not keep documentation for the inspections.
The inspection also revealed that Medical Maggots and LeFlap device is misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), because your firm failed to submit a written report to FDA within 10 working days of initiating the correction or removal of a device initiated by such a manufacturer or importer if the correction or removal was initiated to reduce a risk to health posed by the device, as required by 21 CFR 806.10(a)(1) and (b). The investigator found that in May 2009, a medical device report was submitted to FDA regarding patient injuries, specifically skin inflammation around wound during maggot therapy. Your firm initiated an investigation, determined that the cause of the skin inflammation was due to antiseptic used on skin before application of the maggots therapy. Your firm took a corrective action to eliminate the risk and informed customers not to apply the wound dressing containing maggots to areas around the wound unless such areas were dry and also to eliminate the use of betadine where therapy was to be administered.
We reviewed your firm's corrective actions and determined that they meet the requirements for Class II recall, which also meet the risk to health threshold as specified in 21 CFR 806.2(j)(2). Your firm submitted a report to FDA dated June 10, 2010, however, the report was not submitted within the ten (10) days' time frame required by 21 CFR 806.10(b). Specifically, your firm was aware of the correction or removal on April 27, 2009, but did not inform the Los Angeles District Office until June 11, 2010 as a result of this inspection.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are 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 approval applications for Class III devices to which the Quality System regulation (21 CFR Part 820) 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 (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 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 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:
Mr. Blake Bevill
Director, Compliance Branch
U.S. Food and Drug Administration
Irvine, CA 92612-2445
If you have any questions about the content of this letter please contact Mr. Esteves at (949) 608-4439.
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 closeout 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 your products into compliance.
cc: California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
P.O. Box 997435
Sacramento, CA 95899-7435