Inspections, Compliance, Enforcement, and Criminal Investigations
Global Protection Corp. 07-Jan-08
Department of Health and Human Services
Public Health Service
New England District
January 7, 2008
Mr. David T. Wedel, President
Global Protection Corp.
12 Channel Street, 6 th Floor
Boston, MA 02210-2323
Dear Mr. Wedel:
During an inspection of your firm located in Boston, Massachusetts on October 31 through November 7, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures male condoms and condom related products. 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, the 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, (C.F.R.), Part 820. We received a response from Mr. Davin T. Wedel dated November 19, 2007, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you on November 7, 2007. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to assure that a process whose results can not be fully verified by subsequent inspection and test, has been adequately validated and approved according to established procedures, as required by 21 C.F.R. § 820.75(a).
For example, the package seal integrity test used in final inspection of the product was not validated. Your firm's In House Package Seal Integrity Testing Procedure QP_20 states "This section outlines a procedure for ensuring the integrity of package sealing operations for compliance with [redacted]. Your firm's procedure does not comply with [redacted] and deviations from the standard have not been validated. In addition, during demonstrated package integrity testing, your firm was not detecting leaks which were observed to be present by FDA personnel. While management acknowledged the existence of "bubble streams" and that they were similar to those observed during your own product testing, you disagreed that the bubble streams constituted a leak. We acknowledge your response to the FDA-483, but we believe that your interpretation that "air bubbles need to indicate a definite leak in the condom package" (page 4) is flawed. [redacted] and [redacted] standard test methods instruct the analyst to look for streams of bubbles which constitute a failure. Further, validation of the [redacted] sealing machine process was not adequate in that validation was conducted using the firm's unvalidated package sealing integrity test.
As you are also already aware, FDA sample #396426 collected as a result of a complaint received through the District of Columbia Department of Health, HIV/AIDS Administration of your condoms, lot # 99007109 failed both the water leakage test and package seam integrity test. Your firm must be capable of detecting these types of serious leak failures and package integrity in the future. We are very concerned with your validation issues and interpretation of test results.
We acknowledge the corrective actions that your firm has initiated to address these concerns. We understand that your firm has made a decision to discontinue the use of [redacted] pouching material in the packaging of condoms and that a new packaging material is being sought and that production will not be resumed until this new material has been validated. To ensure compliance with the standard, we are requesting that you supply us with the validation data for this new material prior to the production of condom packages for sale and distribution.
2. 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, as required by 21 C.F.R. § 820.80(d).
For example, your firm's In House Waterleak Testing Procedure QP_19 did not state criteria for acceptance or rejection of a lot. The Pinhole/Leakage Water Testing Data Collection Form QF_45 utilizes [redacted] as reference for acceptance/rejection of a lot. Lots 12004153 and 12004154 both failed your firm's established acceptance criteria, yet your firm tested other samples from the same lots at [redacted] and made concessions to pass the lots for U.S. distribution only. Your firm failed to view the test results as a nonconformance and made exceptions for not meeting your own standard.
We acknowledge your response to the FDA-483 indicating that you have updated QP_19 In House Waterleak Testing Procedure to include criteria for acceptance or rejection of a lot in accordance with [redacted]. However, your statement that both lots tested met U.S. standard, [redacted] is not acceptable because your firm tests according to [redacted].
3. Failure to identify and document the actions needed to correct and prevent recurrence of nonconforming product and other problems, as required by 21 C.F.R. § 820.100(a)(3) and (b).
For example, CAPA 200411 resulted in a finding that your firm could not obtain an adequate package seal with its [redacted] sealing machine for every lot of a given material at the speed, temperature and pressure stated in the package sealing process validation. Your firm never changed the list of approved speed, temperature and pressure settings for package sealing for this material. CAPA 2004-11 did not document the full investigation of the non-conformity.
We acknowledge your response to the FDA-483 indicating that you will review and update your Sealing Process Validation and Related Materials, Pressure, Temperature, and Speed Validations procedure QP_38, as well as retrain the appropriate personnel in the updated procedures. We are requesting that you provide us with the process change re-verification/re-validation information.
4. Failure to have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by their position are correctly performed, as required by 21 C.F.R. § 820.25(a).
For example, your firm employs one individual in the quality department. This individual does not have the education, background, training or experience to manage the quality department of your medical device firm. Further, internal audits of the Quality Control System and the Regulatory Department were conducted by an individual with no documented training in performing internal audits.
We acknowledge your response to the FDA-483 indicating that the current quality manager is no longer performing quality functions and that you have hired a regulatory consultant, [redacted] to assist you in revisions of your quality system procedures, internal auditing, training and hiring of qualified staff for your quality department.
5. Failure to conduct quality audits at sufficient regular intervals, as prescribed by internal procedures, to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 C.F.R. § 820.22. Further, quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 C.F.R. § 820.22.
For example, in reviewing quality audits for 2006 to the present, it was observed that your firm had not conducted the September 2006 Product Assembly Audit, the November 2006 and April 2007 Disposal and Control of Non-Conforming Product audit, and three of the four Contract Manufacturer audits as required by your firm's Internal Audit Procedure QP_40. Further, the individual who conducted the Disposal and Control of Non-Conforming Product audit has direct responsibility for the disposal and control of non-conforming product.
We acknowledge your response to the FDA-483 indicating that you have hired a regulatory consultant, [redacted] to assist you in internal auditing and scheduling, overall audit planning and execution, and audit training. As noted, internal audits must be performed by personnel with responsibilities independent of the audit area.
6. Failure to ensure that equipment is routinely calibrated, inspected, checked and maintained, as required by 21 C.F.R. § 820.72(a).
For example, the [redacted] was not calibrated in accordance with the manufacturer's recommendation of annual calibration. The Calibration Certificate provided by your firm indicated that this unit was last calibrated on February 20, 2003, but the sticker on the unit indicated the last calibration was performed on July 30, 2004. This pyrometer is used in the calibration of the Pinhole/Leakage Water Test Machine per QP_22 Calibration Procedure. Further per QP_22 Calibration Procedure, the [redacted] sealing rollers are calibrated for seal integrity by testing packages using the package seal integrity test which was determined to be unvalidated. Additionally, [redacted] displays a sticker noting the last calibration was performed on December 4, 2004. The calibration certificate for this unit could not be located. In a demonstration of the roller calibration, the pyrometer consistently read more than 40°F less than the machine readout, and it dropped to 115°F when the unit was removed from the roller, indicating that it was not functioning properly.
We acknowledge your response to the FDA-483 indicating that the [redacted] the [redacted] have been sent to a certified calibration laboratory for recalibration and that henceforth these instruments will be calibrated in accordance with the manufacturer's recommended schedule of calibration. Prior to resumption of production with new packaging material, your [redacted] sealing rollers must be calibrated for seal integrity. Hence, your package seal integrity test must also be validated for this new material. We request that you supply us with the package seal integrity test validation.
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 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 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.
As already described in the body of the Warning Letter, we look forward to reviewing further documentation of your firm's proposed corrective actions. We also look forward to reviewing the proposed changes being contemplated to your overall quality systems that will serve to demonstrate that your firm has the capability to prevent the recurrence of the very serious violations noted above.
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, issued at the closeout of the inspection may be symptomatic of serious problems in your fin'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.
Your response should be sent to: Karen N. Archdeacon, Food and Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact: Ms. Archdeacon at 781 596-7716.
Michael R. Kravchuk
Acting, District Director
New England District
Attachment: FDA-483 dated November 7, 2007