Inspections, Compliance, Enforcement, and Criminal Investigations
Global Manufacturing & Engineering, LLC 30-Jun-05
Department of Health and Human Services
Public Health Service
New Orleans District
June 30, 2005
WARNING LETTER NO. 2005-NOL-27
Mr. Carl M. Crawford, Owner
Global Manufacturing & Engineering, LLC
6525 Sunplex Drive
Ocean Springs, MS 39564
Dear Mr. Crawford:
On January 5 - 6, 2005, a U.S. Food and Drug Administration (FDA) investigator inspected your medical device contract manufacturing facility, located at 6525 Sunplex Drive, Ocean Springs, Mississippi. This inspection determined your firm manufactures metal bone screws, connectors, and hooks which are medical devices within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321]. These Class II medical devices are not exempt from the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulations, as specified in Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). Also, these devices are not exempt from the medical device reporting requirements of the Medical Device Reporting (MDR) regulation, as specified in Title 21, Code of Federal Regulations, Part 803 (21 CFR 803). You can find the Act and the CFR through links in FDA's home page at http://www.fda.gov.
Our inspection determined your devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], as the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformance with the CGMP requirements of the QS regulations for medical devices, as specified in 21 CFR 820. Specific violations follow:
1. Failure of management with executive responsibility to ensure 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. Specifically, the procedures in your firrn's Quality Manual are not consistent with your actual current organization structure nor current quality system operations.
2. Failure to review associated data and documentation before release of finished devices, as required by 21 CFR 820 .80(d)(2). Specifically, our investigator's audit of [redacted] device history records showed [redacted] records lacked evidence of review prior to device product release.
3. Failure to conduct quality audits to verify the quality system is effective in fulfilling your quality system objectives, as required by 21 CFR 820.22. Specifically, your firm does not conduct required quality audits.
4. Failure to conduct quality system management reviews at the defined intervals, as required by 21 CFR 820.20(c). Specifically, to date, your firm has conducted no such annual reviews as defined by your management review procedures.
5. Failure to appoint a management representative to ensure quality system requirements are met and to report to management on the performance of the quality system, as required by 21 CFR 820.20(b)(3). Specifically, there is no documentation your firm has ever appointed a management representative to ensure quality system requirements are met.
b. Failure to assign appropriate responsibility and authority, and to provide independence and authority, to personnel who manage, perform, and assess work affecting quality, as required by 21 CFR 820.20(b)(1). Specifically, although your firm's [redacted] your firm's procedures do not assign him appropriate responsibility and authority. Also, he lacks the independence from production necessary to effectively manage the quality system.
7. Failure to establish calibration procedures with specific directions and limits for accuracy and precision and with provisions for remedial action, as required by 21 CFR 820.72(b). Specifically, you have no calibration procedures for measurement tools such as, but not limited to, calipers and micrometers.
8. Failure to analyze or trend sources of quality to identify existing and potential causes of nonconforming product or other quality problems, as required by 21 CFR 820.100(a)(1). Specifically, your firm does not analyze or trend quality data.
Our inspection also determined your devices are misbranded within the meaning of Section 502(t)(2) of the Act as you failed to develop, maintain, and implement written medical device reporting (MDR) procedures, as required by 21 CFR 803.17. Specifically, your firm has no written MDR procedures.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA 483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.
Federal agencies are advised of the issuance of all warning letters about devices, so they may take this information into account when considering the award of contracts. Additionally, no pre-market submissions for Class III devices to which the Quality System/GMP deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
We recognize at the close of the inspection you made a verbal commitment to correct the observed deficiencies . However, you should notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure similar violations will not recur. You should include in your response copies of documentation such as updated Quality Manual; device history records showing review prior to product release; MDR procedures; annual management quality system review; documentation of quality system management representative appointment; calibration procedures for measurement tools; and, analysis and trending of quality data. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
Your reply should be directed to the U.S. Food and Drug Administration, Attention: Nicole F. Hardin, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Ms. Hardin at (504) 253-4519.
H. Tyler Thornburg
New Orleans District