FDA_483_B&L_Valeant_Feb2016
483 Form issued by the FDA on February 2016 to Bausch and Lomb/ Valeant in Tampa, FL. which describes Quality Control Issues that, I claimed @ Whistleblower law suit. Interest to mention that Bausch and lomb /valeant hide the requested 483's from the years when I worked as a Quality Control Inspector. 483 Form issued by the FDA on February 2016 to Bausch and Lomb/ Valeant in Tampa, FL. which describes Quality Control Issues that, I claimed @ Whistleblower law suit. Interest to mention that Bausch and lomb /valeant hide the requested 483's from the years when I worked as a Quality Control Inspector.
D ISTRICT ADDRESS AND PHONE NUMBER 555 Winder ly Place, Suit e 200 Mait land, FL 32751 (407) 475-4700 Fax: (407) 475-4768 DEP ART!\fi:NT OF HEALTH AND HUMAi'l SERVICES FOOD AND DRUG ADMINISTRATION DATE(S) OF INSPECTION 2/8/2016- 2/25/2016* FEJNUMBER 1000113778 NAME AND TITLE OF INDM OUAL TO WHOM REPORT ISSUED I van (nmi) Car t agena , Executi ve Di rect or of Pl ant Ope r a t ions F IRM NAME STREET ADDRESS Bausch & Lomb, I nc. 8500 Hidden River Pkwy C ITY. STATE. ZIP CODE. COUfflRY TYPE ESTABLISHMENT INSPECTED Tampa, FL 33637- 1014 St erile Drug Manufact urer _......""·""'' conu·ols established after the compmmding of is adequate to monitor, address '-'ll.I.U ll .•" in a state of conu·ol. The fum onrneutt. the orc>ce:ss steps, were as current m-process conu·ols do not adequately momtor output of the manufacturing process and address potential variability. *DATES OF INSPECTION 2/08/2016(Mon),2/09/2016(Tue),2/ 10/201 6(Wed),211112016(Thu),2112/2016(Fri),2116/2016(Tue),2118/ 20 16(Thu ),2/25/20 16(Thu) SEE REVERSE OF THIS PAGE EMPLOYEE(S) SIGNATURE Michael H Tollon, Invest i gat or Denise M Digiulio, FDA Cent er Empl oyee or Employee of Ot her Federal Agenci es -- X ,.;dlael H Tollon Mdllei" Tdon SJgfWid bf: MI!Nd H. Tallon ·S DATE ISSUED 2/25/2016 FORM FDA 483 (09/08) PREVIOUS EDmON OBSOLETE INSPECTIONAL OBSERVATIONS PAGE80F8PAGES
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D ISTRICT ADDRESS AND PHONE NUMBER<br />
555 Winder ly Place, Suit e 200<br />
Mait land, FL 32751<br />
(407) 475-4700 Fax: (407) 475-4768<br />
DEP ART!\fi:NT OF HEALTH AND HUMAi'l SERVICES<br />
FOOD AND DRUG ADMINISTRATION<br />
DATE(S) OF INSPECTION<br />
2/8/2016- 2/25/2016*<br />
FEJNUMBER<br />
1000113778<br />
NAME AND TITLE OF INDM OUAL TO WHOM REPORT ISSUED<br />
I van (nmi) Car t agena , Executi ve Di rect or of Pl ant Ope r a t ions<br />
F IRM NAME<br />
STREET ADDRESS<br />
Bausch & Lomb, I nc.<br />
8500 Hidden River Pkwy<br />
C ITY. STATE. ZIP CODE. COUfflRY<br />
TYPE ESTABLISHMENT INSPECTED<br />
Tampa, FL 33637- 1014<br />
St erile Drug Manufact urer<br />
_......""·""'' conu·ols established after the compmmding of<br />
is adequate to monitor, address<br />
'-'ll.I.U ll .•"<br />
in a state of conu·ol. The fum<br />
onrneutt. the orc>ce:ss<br />
steps, were as current m-process conu·ols do not<br />
adequately momtor output of the manufacturing process and address potential variability.<br />
*DATES OF INSPECTION<br />
2/08/2016(Mon),2/09/2016(Tue),2/ 10/201 6(Wed),211112016(Thu),2112/2016(Fri),2116/2016(Tue),2118/<br />
20 16(Thu ),2/25/20 16(Thu)<br />
SEE REVERSE<br />
OF THIS PAGE<br />
EMPLOYEE(S) SIGNATURE<br />
Michael H Tollon, Invest i gat or<br />
Denise M Digiulio, <strong>FDA</strong> Cent er Empl oyee or<br />
Employee of Ot her Federal Agenci es<br />
--<br />
X ,.;dlael H Tollon<br />
Mdllei" Tdon<br />
SJgfWid bf: MI!Nd H. Tallon ·S<br />
DATE ISSUED<br />
2/25/2016<br />
FORM <strong>FDA</strong> <strong>483</strong> (09/08)<br />
PREVIOUS EDmON OBSOLETE INSPECTIONAL OBSERVATIONS PAGE80F8PAGES
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