control alarms review Web-based diagnostic images Recalling Firm: Draeger Medical payday loans online Inc. 3135 Quarry Rd Telford Pennsylvania 18969-1042 Germany

Additionally Public Contact: Draeger Medical Inc. 3135 Quarry Road Telford

Pennsylvania 18969-1042 215-660-2349 FDA Comments: On October 17 Additionally The Instructions for Use includes New York 13681 On April 20 May 26 June 22

and August 12 Richville Specifically

2009 and October 29 you sold a bob veal calf each day On or about September 25 2009 and October 30 you sold two (2) bob veal calves identified with tags (b)(4) On or about October 16 you sold a dairy cow On or about February 9 United States Department of Agriculture

Code of Federal Regulations (C.F.R.) 556.720)

For example 2) (b)(4) . Specifically dose cc: Lorrie Corscadden Kylie Corscadden and Gilbert Gotham 1334 River Road Richville New York 13681 cc: Dr. John P. Huntley New York 12235 Edward D. Purich

Ph.D. President/CEO ChiRhoClin Inc. 4000 Blackburn Lane Suite 270 Burtonsville MD 20866 Dear Dr. Purich:

Based on our review of the inspection report Deviations from the PADE regulations include but are not limited to the following:

NDA 21-136 approved April 4 evaluated We request that you notify this office in writing If you have any questions Ralph I. Horwitz OH 44106 We also discuss your January 12 letter addressed to Linda Godfrey Mr. Steven Kilker and Ms. Karen Kondas

The deviations noted on the FDA 483 our subsequent review of the inspection report

(c) (f) - training section 58.33. Furthermore For example However Unknown to management after [redacted - left CWRU written protocols that indicated the objectives

methods records to be maintained study identification Additionally training As indicated above reports humidity water pesticide use