Inspections, Compliance, Enforcement, and Criminal Investigations
Southern Implants, LLC 25-Aug-05
Department of Health and Human Services
Public Health Service
2098 Gaither Road
AUG 25 2005
Mr. Graham Blackbeard
Southern Implants, LLC
No. 1 Albert Road
P.O. Box 605
Dear Mr. Blackbeard:
During an inspection of your firm located in Irene, South Africa, on April 11 through 14, 2005, our investigator determined that your firm manufactures endosseous implants. These products are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)).
This inspection revealed that these devices appear to be 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. Significant violations include, but are not limited to, the following:
1. 21 CFR 820.75(a)
Failure to validate and approve a process whose results cannot be fully verified by subsequent inspection and test according to established procedures, as required by 21 CFR 820.75(a). For example, the process for the sterile blister packaging used for all implants has not been adequately validated. The approved validation protocol and report, [redacted] concluded the process for the sterile packaging is not validated.
2. 21 CFR 820.100(a)(6)
Failure to submit information on identified quality problems and corrective actions for review by management, as required by 21 CFR 820.100(a)(6). For example, the fact that the validation study did not meet the pre-determined specifications was not communicated to management.
3. 21 CFR 820.100(a)(4)
Failure to verify or validate corrective and preventive actions to ensure that the action is effective and does not adversely affect the finished device, as required by 21 CFR 100(a)(4). For example, the firm does not have a procedure for verifying or validating the corrective and preventative actions.
4. 21 CFR 820.100(a)(3)
Failure to identify all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified, as required by 21 CFR 820.100(a)(3). For example, Corrective Action [redacted] was issued after a complaint was received that an incorrect component was used in the assembly of the device, the correction was to retrain the operator, the procedure that conflicted with the Device History Record (DHR) was not corrected.
5. 21 CFR 820.100(a)(2)
Failure to have complete corrective and preventive action procedures addressing the investigation of the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2). For example, an "internal" complaint investigation conducted to determine the cause of a label mix-up concluded that the incorrect labels were issued, however the DHR does not support that conclusion.
6. 21 CFR 820.22
Failure to adequately perform quality audits, as required by 21 CFR 820.22. For example, the quality audit did not detect that a process that cannot be fully verified by inspection was not validated.
7. 21 CFR 820.20
Failure of management with executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 CFR 820.20.
8. 21 CFR 820(b)(1)
Failure to provide employees who manage, perform, and assess work effecting quality with the independence and authority to accomplish their work, as required by 21 CFR 820(b)(1). Specifically, the Management Representative for Quality (MRQ) does not have the authority to ensure the quality system requirements are effectively established. For example, the MRQ does not have the authority to initiate preventative actions.
9. 21 CFR 820 .40(a)
Failure of the documentation of approval of documents to include the document approval date and the signature of the approving official, as required by 21 CFR 820.40(a). For example:
a. The receiving, in-process, and final acceptance activity procedures have not been approved.
b. The labeling contained within the Master Device Record.
c. There are two different versions of the document control procedure, version 6, dated October 12, 2004 (signed October 5, 2004).
10. 21 CFR 820.30(i)
Failure to follow procedures for the documentation, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, Paragraph 6.8 of [redacted] states "Any change to the design are identified, documented, validated or where appropriate verified, reviewed and approved before their implementation." This procedure was not followed for the following changes:
a. The specifications of the drawing for Implant IB were changed on January 22, 1998 to revision 7 and then to revision 8 on September 29, 1999; however, the change authorizations updating the drawing from revision 3 directly to revision 7 and from revision 7 to revision 8 were not approved until January 3, 2005.
b . The specification of the drawing for Implant BB were changed on January 21, 1998, to revision 6 and then from revision 6 to revision 8 on April 13, 1998; however, the change authorizations updating the drawing from revision 5 to revision 6 and from revision 6 to revision 8 were not approved until January 6, 2005.
We received your response dated April 30, 2005, and your undated response, which we received on June 27, 2005, concerning our investigator's observations noted on the Inspectional Observations, Form FDA 483 (FDA 483). It appears that these responses are adequate. However, a follow-up inspection will be required to assure that corrections are adequate. We will contact the appropriate people and request an establishment reinspection. A Food and Drug Administration (FDA) trip planner will be in touch with you to arrange a mutually convenient date for this inspection.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by the 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 underlying 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.
If you need help in understanding the contents of this letter, please contact Mr. Ronald L. Swann, Chief, Dental, Ear, Nose, Throat, and Ophthalmic Devices Branch, Center for Devices and Radiological Health, HFZ-331, 2094 Gaither Road, Rockville, Maryland 20850, or at (240) 276-0115 or FAX (240) 276-0114.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and Radiological Health