19th of June To Whom It May Concern: Reference: FDA Compliance letter for Omnicell Inc., Blister and Foil Packaging Materials.
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1 19th of June 2017 To Whom It May Concern: Reference: FDA Compliance letter for Omnicell Inc., Blister and Foil aging Materials. This certification refers to the blister and foil packaging materials manufactured by Omnicell Inc. ( Omnicell ). These materials are suitable for packaging oral solid medications and comply with all the applicable requirements of the U.S. Federal Food, Drug, and Cosmetic Act and the Food Additive Regulations as described in the attached documents. We thank you for selecting Omnicell products and trust that you will find this to be adequate assurance of our products compliance with the regulations administered by the Food and Drug Administration (FDA). Should you have further questions, please do not hesitate to contact me at (800) , ext or via at brett.smith@omnicell.com. With kind regards, Brett A. Smith Sr. Manager, Procurement 2003 Gandy Boulevard North St. Petersburg, FL Fax
2 The blister item components referred to as blisters comply with the following: * Small 28 Dose Blister 500/Case A Amber Medium 28 Dose Blister 500/Case Medium 28 Dose Blister 500/Case A Amber Medium 28 Dose Blister 500/Case Large 28 Dose Blister 500/Case J Jumbo 28 Dose Blister 500/Case PVC manufactured to FDA standard Title 21 CFR Sections , , and PVC manufactured to FDA standard Title 21 CFR Sections , , and JA X-Large 28 Dose Blister 500/Case PVC manufactured to FDA standard Title 21 CFR Sections , , and Dose 5 X 7 Blister 500/Case A Amber 35 Dose 5 X 7 Blister 500/Case Dose Perf d Blister Small 35 Dose 5 X 7 Blister PVC manufactured to FDA standard Title 21 CFR Sections , , and
3 205-05XL Large 1X 5 Blister 250/Box Medium 28 Dose Tri-Fold SureMed 10X6.5 Blister SureMed 10X6.5 Blister SureMed 10X6.5 Blister The foil item components referred to as lidding comply with the following: * LBL, MTS-STK, RX MAP FOIL N- PERF, D #863 10,000/Case Lidding manufactured to FDA standard Title 21 CFR Sections , , , LBL, MTS-STK, RXMAP(7X5)CARDPERF, D#866 10,000/Case Lidding manufactured to FDA standard Title 21 CFR Sections , , , The card item components referred to as punch cards comply with the following: Day (28-Dose) PS Bio Card Lidding manufactured to FDA standard Title 21 CFR Sections , , , 3
4 Day (28-Dose) HS Card 500/Case Day (28-Dose) PS Card Day (28-Dose) HS Card X 7 (35-Dose) PS Card * 5 X 7 (35-Dose) HS Card Week (28-Dose) HS Card 500/Case Week (28-Dose) PS Card Tri-Fold Multidose (28) PS Card Tri-Fold Multidose (28) HS Card 4
5 X 4 Perf d Tri-Fold HS Card Flex Barcode N 5 X 7 (35 Dose) Perf d HS Card X 5 PS Card X 7 DUO PS Card Day (28-Dose) PS Card Week (28-Dose) HS Card 500/Case M * 5 X 7 (35-Dose) PS Card M 7 X 4 Perf d Tri-Fold HS Card Flex Barcode Day (28-Dose) PS Card 5
6 Tri-Fold Multidose (28) PS Card German SureMed 28 PS 2PNL German SureMed 28 PS 2PNL German SureMed 35 PS 2PNL 6
7th of November To Whom It May Concern: Reference: FDA Compliance letter for Omnicell Inc., Blister and Foil Packaging Materials.
7th of November 2017 To Whom It May Concern: Reference: FDA Compliance letter for Omnicell Inc., Blister and Foil aging Materials. This certification refers to the blister and foil packaging materials
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At the Warwick Conference Center, P.O. Box 349, 62 Warwick Center Road, Warwick, NY 10990 Phone: 845-986-1164 / Fax: 845-986-8874 / Email: warwickcc@optimum.net January, 2017 Dear Friend of Camp Sunrise,