[DEPARTMENT OF HEALTH AND HUMAN SERVICES "F000 ANO DRUG ADMINISTRATION STRICT OFFICE AGORESE AND PHONE NUMBER (BATES) OF WSPECTION 10903 New Hampshire Avenue, Bldg St Room 4225 0221-93/012017 Silver Springs, Maryland 20993 (G01) 796-3334 Fax (301) 847-8738 FerNMaER 3005430968 [STREET ADDRESS CCadita Healthcare Limited ‘Swaraj Majra, Judi Kalan, Tehsil fev. STATE AND ZP CODE -77PE OF ESTABLISHMENT RSPECTED ‘Baddi, Dist. Solan, Himachal Pradesh 173205 india Drug Manufacturer Tris DOCUMENT USTS OBSERVANIONS NADE BY THE FOR REPRESENTATIVE(9) OURHG TE NOFEGTION OF YOUR FASILITY. NEW ARE NEREOTIONNL DaseRvATONS, 9 OC NOT REPRESENT A FINAL AGENCY DETERMINATION REGARORVG YOUR COMPLIANCE. IF YOU HAVE AN OBJECTION REGARDING AN BOSERVATION, OR HAVE IMPLEMENTED. Of PLAN TO RIPLEMENT CORRECTNE ACTION IV RESPONSE TO AN OBSERVATION. YOU MAY DISCUSS THE J SBJeCTION OF ACTION WM THe FOA REPRESENTATIVES) OURING THE INSPECTION OR SUBMIT THES INFORMATION TO FDA AT THE ADORESS ABOVE. IF YOU HAVE ANY QUESTIONS. PLEASE CONTACT FDA AT THE PHONE NUMBER AND ADDRESS ABOVE. DURING AN NSPECTION OF YOUR FIRM (NE) OBSERVED: JObservation | {Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. pecifically, not all manufacturing equipment for use in production ofl! Capsules, USP img andl” mg has been qualified. A. The manufacturing area to be used in the commercial production off) Capsules, USP , referenced in applicatior! 40 Ill] has not been qualified. Commercial manufacturing not complete on the®4®U 0 lll line or the opening to the facility and qualification of the area has not been completed. lowing equipment to beysed in the production offi Capsules, USP im was relocated to Lit nd has not been qualified: "EUPLOVEE(S) WINE AND THLE anor Teo) ‘Nicole E. Knowiton, Investigator Maria. Estella, Investigator FORM FOA 195 (00H) PREOUS COTTON OOSCUETE TNSPECTIONAL OBSERVATIONS Page 1ofsDEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMANISTRATION BRSTRICY OFFICE AGORESE AND PHONE HUMBER [DRTEIS) OF REPECTION 10903 New Hampshire Avenue, Bldg 51 Room 4225 02/21-03/01/2017 Silver Springs, Maryland 20993 Leame— (301) 796-3334 Fax (301) 847-8738 aan) 3005430968 STREET ADDRESS ‘Swaraj Majra, Jaddi Kalan, Tehsit [TYPE OF ESTABLIGHWENT RESPECTED ‘addi, Dist. Solan, Himachal Pradesh 173205 India Drug Manufacturer lObservation 2 Master production and control records lack complete manufacturing and control instructions. JA. The batch manufacturing records for’ ‘apsules USP P2%mg and’! limg exhibit respectively) and intended batch of the batch manufacturing records state Firm management stated during production of the exhibit batches the® 4] was) manually There is no documentation of how the manual operation was performed. in the batch records for the exhibit batches: ¢ intended batch manufacturing records BMR/ZB/0586-00 and BMR/ZB/0587-00, [Batch production and control records do not include complete information relating to the production and control of| jeach batch. A. The batch manufacturing records for! capsules USPP mg and ng exhibit batches respectively) and intended bate) "EWP VEETS) ME AND TLE Pao Tipe) DATE BETES cole. Kaoston, Investigator Maria Estella vestigate osio12017 FORWFDA 485 (708) PREVIOUS EOTTION OBSOLETE INSPECTIONAL OBSERVATIONS Page orsDEPARTMENT OF HEALTH AND HUMAN SERVICES F000 AND DRUG ADMINISTRATION BRTRICT OFFICE AGDRESS AND PHONE ROMER DATESTOF WEPESTION 10903 New Hampshire Avenue, Bldg $1 Room 4225 o2/21-03/0172017 Silver Springs, Maryland 20993, (301) 796-3334 Fax (301) 847-8738 Industry Information: wor fa gov/oc/indusry 10: Mr. Ravindra Kumar Goyal, Plant Head Fa NAME BREET ORES Cadila Healthcare Limited ‘Swaraj Mara, Jude Kalan, Tehsil len. stare Aww Z COE VRE OF ESTALIGHENT NEPECTED ‘Baddi, Dist. Solan, Himachal Pradesh 173205 India g manufacturing }Firm management stated during production of the exhibit batches ‘he onc. There is no documentation of how the manual operation was performed. B, Firm management stated the filled"! capsules usp lng andl me wer 8 a required step in the manufacturing process. There is no instruction for use or reference to tl in the batch records for the exhibit batches| and or the intended batch manufacturing records BMR/ZB/0586-00 and BMR/ZB/0587-00. [C. During the manufacture of ‘apsules USP!" mg exhibit batches the results for theoretical yield were not within the set parameters o| ,. The results obtained for batch , and@™® 4, respectively, A deviation investigation was not i ‘umentation in the batch records regarding this discrepancy. iated and "BWPCOYEEIS) NAME AND TTLE Pato rae) DATE RSD [Nicole E Knowlton, lvestigator Maria E. Estella Investigator jesouant7: INSPECTIONAL OBSERVATIONS Pages of3