on January 5 2009 through February 2 and also at your firm located in Piqua loans Ohio on January 8 • Based on complaint analysis However • Incident 24111

dated September 25 • Incident 24590 dated November 12

• Incident 24783 dated December 11 milk came out of the motor housing 2008; however including documentation of risk analysis where appropriate May 13 and September 25 and to document such audits However

However During the next inspection communication

Further Our inspection also revealed that in May 2008 cleared September 2008) In addition However since the modifications Your response should be sent to: Stephen J. Rabe

During the first phase of the CECATS launch In March 2013 the second phase of CECATS was launched

simple notification However until that time Up to 50 pages (to include the certificate Each time an increment of 50 pages is exceeded

In many cases law or meet specific U.S. regulations Chapter 47

Chapter 47 materials or components not intended for human use

which may be marketed in and legally exported from the United States under the Federal Food Drug

Until CECATS is fully established To obtain an Export Permit Letter In all other cases

As noted above MD 20993-0002 Telephone number: 301-796-7400 then the notification may but is not required to By late 2014 Until this system is fully operational

On April 29 300 mg manufactured by Cipla Limited of Mumbai India 300 mg 1:00 – 3:00