FDA-483实例.docVIP

Note: Although this FDA-483 is an accurate representation of the original FDA-483 issued to the firm, it is not an exact copy. Slight modifications to the original FDA-483 have been made to accommodate its conversion to the HTML format. A scanned copy of the original FDA-483 is available in PDF format on this website. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT OFFICE ADDRESS AND PHONE NUMBER60 Eighth Street NEAtlanta, GA 30309(404) 253-1161 Fax:(404) 253-1202 DATE(S) OF INSPECTION03/22/2006 - 05/15/2006 FEI NUMBER1032500 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUEDTO: Mr. Thomas H. Eggleton, VP of Operations FIRM NAMEBausch Lomb Inc. STREET ADDRESS8507 Pelham Rd CITY, STATE AND ZIP CODEGreenville, SC 29615-9598 TYPE OF ESTABLISHMENT INSPECTEDMedical Device/Pharmaceutical Manufacturer This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above. The observations noted in this Form FDA-483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the quality system requirements. DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: OBSERVATION 1 The design plan does not describe the design and development activities, define responsibility for implementation of design and development activities, and identify and describe the interfaces with other groups or ac