Inspections, Compliance, Enforcement, and Criminal Investigations
Swiss American Products, Inc. 18-Sep-08
Department of Health and Human Services
Public Health Service
September 18, 2008
RETURNED RECEIPT REQUESTED
Mr. William O. Kling, CEO
Swiss American Products, Inc.
2055 Luna Road, Suite 126
Carrollton, Texas 75006
Dear Mr. Kling:
During an inspection of your firm located in Carrollton, Texas, on August 12 through 15, 19, 27, 2008, and September 4, 2008, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures and distributes wound care products which include the Elta® Hydrovase Gel, Elta® Silver Antimicrobial Wound Gel, Elta® Wound Gel, Elta® Wound Cleanser, Elta® Impregnated Gauze, and Elta® Soft Gauze. The Elta® Silver Antimicrobial Wound Gel is indicated for prescription use for the management of partial and full thickness wounds under the supervision of a healthcare professional, and OTC use for the management of minor burns, cuts, laceration, abrasion, and minor skin irritations, as stated in your firm's 510(k) K071703. 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, its 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.
The FDA investigator issued the observations, which are listed on the Form FDA 483 (List of Inspectional Observations), to you at the end of the inspection. You verbally annotated on the FDA 483 as "promised to correct" for thirteen of the fifteen inspectional observations and "corrected and not verified" for two remaining inspectional observations. On September 16, 2008, your Chief Operating Officer (COO), Ede Payne, hand-delivered a response, dated September 16, 2008, to our investigators' inspectional observations and held a brief meeting with FDA Compliance Officer Thao Ta. Overall, your firm's response does not completely resolve the inspectional observations for the reasons explained in this warning letter. The Agency will conduct follow-up inspections to assure that your firm's corrections are adequate.
These violations include, but are not limited to, the following:
Quality System Violations
1. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device and the needs of the user and patient; that design input procedures include a mechanism for addressing incomplete, ambiguous, or conflicting requirements; and that the design input requirements shall be reviewed, approved, and documented by designated individual(s), as required by 21 C.F.R. 820.30(c). Specifically, your firm did not have any written and approved design input requirements for the Elta® Silver Antimicrobial Wound Gel.
2. Failure to establish and maintain a device design history file for each type of device to include or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the design control requirements of 21 C.F.R § 820, as required by 21 C.F.R § 820.300). Specifically, your firm has not maintained a formal design history file for the Elta® Silver Antimicrobial Wound Gel to include documentation of design plans, design input requirements, design outputs, design reviews, design risk analysis, design changes, design verification or validation, and design transfer.
3. Failure to establish and maintain adequate procedures for validating the device design to ensure that the device conforms to user needs and intended uses; that acceptance criteria are established prior to performing validation activities; that design risk analysis is conducted and documented; that testing of production units is conducted under actual or simulated use conditions; and that the design validation results are documented, as required by 21 C.F.R. § 820.30(g). Specifically,
a. During the design development of the Elta® Silver Antimicrobial Wound Gel, your firm has not validated the mixing process nor tested the finished devices to ensure that they contain the correct and homogenous silver nitrate concentration of [redacted] as your firm verbally stated during the inspection and documented in your device labeling that was included in your firm's Supplement 1 of the 510(k) submission.
b. Your firm has not conducted and documented a risk analysis for the Elta® Silver Antimicrobial Wound Gel, where appropriate.
4. Failure to adequately validate manufacturing processes, whose results cannot be fully verified by subsequent inspection and test, with a high degree of assurance, and approve and document the results of the validation activities to ensure that product specifications can be consistently met, as required by 21 C.F.R. § 820.75(a). Specifically, your firm has not validated the mixing process for the following products:
a. The Elta® Silver Antimicrobial Wound Gel to ensure that it contains the correct and homogenous sliver nitrate concentration of [redacted] as intended.
b. The gel or ointment used in the contract manufacturing of other medical devices (e.g., Product Item # HE-T003, AB-B002, AB-G04/005, ABT003/004/005/006, and PM40047).
5. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria and that acceptance activities are documented and reviewed prior to releasing the devices for distribution, as required by 21 C.F.R. § 820.80(d) and 820.80(e). Specifically, your firm has not defined acceptance criteria and tested each lot of the Elta® Silver Antimicrobial Wound Gel for silver nitrate concentration and bacterial kill rate effectiveness. See Batch Record for Lot # 19351. Device history record for Lot # 19351 documented that your quality control staff was to collect a sample of [redacted] of the bulk Elta® Silver Antimicrobial Wound Gel for bacterial kill rate testing. However, you stated that this test was not a release requirement and was done for informational purposes only.
6. Failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality, as required by 21 C.F.R. § 820.70(e). Specifically, your firm did not always follow its SOP 2-03 "Cleaning & Sanitizing Manufacturing Tanks and Kettles," Revision 2, effective 3/27/07, in that your firm did not always record, date, and sign entries in the log book for the cleaning, sanitization, or re-sanitization of the manufacturing equipment used to manufacture medical devices, drugs (sunscreen), and cosmetics to ensure that these products are not cross contaminated between production runs.
7. Failure to establish and maintain procedures to review, approve, and document changes to documents, and communicate approved changes to the appropriate personnel in a timely manner, as required by 21 C.F.R § 820.40(b). Specifically, your firm did not use the Document Change Request (DCR) form, as required by your SOP-0-01 "Document Control," Revision 7, effective 9/14/07, to document approval and signature of the approving individual(s), a description of the change, and a justification for the change to the mixing instructions of the raw materials used to manufacture of the Elta® Silver Antimicrobial Wound Gel on 11/27/07 as shown in Batch Record # B08508.
8. Failure to document and maintain the product labels and labeling for each finished device or each lot/batch of the finished devices in the device history record, as required by 21 C.F.R. § 820.184 and 820.120. Specifically, your device history record did not include a copy of the approved package insert, and where used, the printed box for each lot of the Elta® Silver Antimicrobial Wound Gel manufactured.
9. Failure to establish and maintain 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 C.F.R. § 820.22. Specifically, your firm's SOP-0-13 "Internal Audit of Quality System," Revision 2, effective 10/15/07, did not cover requirements to audit management responsibility, design controls, purchasing controls, and document controls of the quality system. Your past audits conducted on dates between 11/29/07 and 1/21/08 did not cover these quality system areas.
10. Failure of management with executive responsibility to appoint and document such appointment of a member of management who shall have established authority and responsibility for ensuring that the quality system requirements are effectively met and maintained, and for reporting on the performance of the quality system to management with executive responsibility for review, as required by 21 C.F.R § 820.20(b)(3). Specifically, your firm has not appointed a management representative and documented the appointment.
Your firm's September 16, 2008, response is incomplete for the following reasons:
1. Your firm still has not defined the specification range (upper and lower limit) for the silver nitrate concentration and conducted assay testing of the finished devices in the current inventory or future production lots to verify whether these devices contain the homogenous silver nitrate concentration of [redacted] as stated in your device labeling and 510(k) submission. Your validation of the mixing (compounding) process should be amended to include the assay test results of silver nitrate concentration. FDA Compliance Officer Thao Ta discussed this issue with your COO during the September 16, 2008 meeting.
2. Your firm's internal audits are not expected to be completed until January 31, 2009. We believe you should conduct internal audits of all of your firm's device product lines as soon as practically possible in order to identify gaps in your firm's quality system.
3. Your firm's response did not provide attachments for your response to FDA 483 Inspectional Observations 8, 9, and 10.
4. Your response to FDA 483 Inspectional Observation 8 stated that your firm has not completed the retroactive mixing (compounding) validation for the two remaining bulk formulations and was awaiting their final laboratory test results. Your firm promised to send additional response by October 5, 2008.
5. Your response to FDA 483 Inspectional Observation 9 did not clearly explain whether your firm will conduct bacterial kill rate test for each future production lot prior to releasing the devices for distribution and document their test results in each lot/batch production record. Mr. Ta discussed this issue with your COO during the September 16, 2008 meeting.
Responding to This Warning Letter
You 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/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, pre-market 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 Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.
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 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.
Reynaldo R. Rodriguez, Jr.
Dallas District Director