DEPAKIMENI OI AND HUMAN SERVICES rl _4 555 Winderley Placer Suite 200 07 2/2010 - 07/14/2010* Maitland, FL 32751 v" (407) 475-4700 Fax: {407) 475-4768 3000215008 Industr Infomation: fda. ov/oc/industr I. Mr . Friedel . Zander, President and Zander Scientific, Inc . DBA Zander IVF, 7 55 Court Inc. Suite 4 . 3' Vero Beach, FL 32965-0790 Medical Device eci fication Developer This document lists observations made by the FDA representntive(sI during the inspection of your facility. They are inspections! observations. and do not represent a final Agency detennination regarding your compliance. lfyou have an objection regarding rin observation. or have implemented. or plan to implement. corrective action in response to an observation. you may discus the objection or with the FDA reprcsentattvels) during the inspection or submit this mlonnauon Lo FDA at the address above. tt' you have any questions please contact Hm ar ure pnone nurrmer anu uoorerm anove. lite observations: noted in this harm I DA-483 are not an exhattstive listing or objectionable Ilmder the Ima, your rt . is for conducting internal to identrgir turd correct may uml all viufutiotrr ofthe system requirements. OBSERVATION I rruceuures wt uesrgn eomror nave not oeen esutousneu. I apeemezuty, your nas not CSIRUUSDCU uestgu. control procedures tor me ueveropmem ot your z.rv1? I IUUC. Photo-Catalytic Arr System. OBSERVATION 2 Procedures eonective and oreventive action have not been established. Snecifically. vour tirm has not established corrective and preventative action orocedures for the soecitication devnlooment of . your IOOC Photo-Catalytic Air System. OBSERVATION 3 Procedures for receiving, reviewing, and evaluating complaints by a fomrally designated unit have not been established. Speeilically, your lirrn has not established complaint handling procedures for the specification development ol` your AVF- l00C Photo?CataIytic Air Purilieation System. ,7 SEE REVERSE Andrea . Norwood, Investigator os nee OW 1? rout In tu INSPIZCTIONAL OBSERVATIONS una 1 or- 1 times nuaknmm or Ann nunnu 555 winderley P1ace, suite 200 07 12/2010 - 07/14/2010* Maitland, FL 32751 (407) 475-4700 Fax: (407) 475-4768 3000215008 dus I fo w. fda. ov/oc/industr Mr . Friedel M. Zander, President and Mh Zander Scienti fic, Inc . DBA Zander IVF, 755 8th Court - . Vero Beach, FL 32965-07 90 Medical Device eci fication Develo er OBSERVATION 4 Procedures for quality audits have not been established. Speciilcally, your firm has not established quality audit procedures for the specification development of your 100C Air Pmitication System. (E OBSERVATION 5 notbeenestablished. Specitically, your Erm has not established purchasing control procedures for the speciication development ofyour IOOC Photo-Catalytic Air System. OBSERVATION Specidcally, your Erm has not established management review procedmes for the specltication development ofyour Afkg mug Aiypuyigmgm 5 oasenvmon 7 Written MDR procedmes have not been developed, maintained, and implemented. - - Specifically, your iirm has not established medical device reporting procedures for the specification development of your IOOC Photo-Catalytic Air System. SEE REVERSE An rea H. Norwood, nvestigator or rl-us race Ly fb1? . mm rm an rumus mmeuonneum INSPECTIONAL OBSERVATIONS nos 2 or 1 races I DILPARIMHT 0I AND HUMAN SERVICES `mn who 555 Winderley Place, Suite 200 07/ /2010 - 07/14/2010* Maitland, FL 32751 .(407) 475-4700 Fax:(407) 475-4768 3000215008 Industr Infomation: ov/oc/industr o' Mr. Friedel M. Zander, President and Mh Zander Scientific, Inc. DBA Zander IVF, 755 8th Court Inc. Suite 4 I Si? f` 5 Vero Beach, FL 32965-0790 Medical Device ecification Develo er Observation Annotations Observation 1: Promised to correct. Observation 2: Prcmisedto correct. i Obrrervationii: Prorniscdtocorrect. Observction4: Promisedtoccrrect. 0bcervntion5: Pmmisedtoconect Obcervetion6: Prcmiscdtocorrect. 3 Obcervation7: Prmnisedtoconcct. i 07Il4f20l0(Wed) (EA - - rj SEE REVERSE Andrea H. Norwood, Inves 'gator - rvourmuu - I nmnnusmrmuucurru INSPECHONALO ERVATIONS