Inspections, Compliance, Enforcement, and Criminal Investigations
Klinge Chemicals Limited - Close Out Letter 10/22/12
| Public Health Service Food and Drug Administration |
| CENTER FOR DRUG EVALUATION AND RESEARCH Office of Manufacturing and Product Quality Division of International Drug Quality International Compliance Team 10903 New Hampshire Avenue Building #51, Room 4221 Silver Spring, MD 20993 TELEPHONE: (301) 796-3916 FAX: (301) 847-8742 |
Department of Health and Human ServicesOctober 22, 2012
Mr. Stephen G. Lockie
QA and Operations Manager
Klinge Chemicals Limited
1 Bessemer Drive
Kelvin Industrial Estate East Kilbride
Glasgow, Scotland
United Kingdom
Reference: FEI 1000429223
Dear Mr. Lockie:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL: 320-11-007, dated December 21,2010. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Maan Abduldayem
Compliance Officer
Division of International Drug Quality
