The following is the second Blog in an on-going series of Blogs obtained from a Warning Letter about Mylan Laboratories, Bangalore, India as well as other Mylan (Agila Specialties Private Ltd.) facilities in India. This second Blog continues the review of the Mylan facilities which were audited February 6-13, 2015 and are located at Plot No. 284-B (19A) Bommasandra Jigani Link … [Read more...]
STILL ANOTHER INDIAN FIRM IS CITED FOR ITS MANAGEMENT OF ITS ISO 5 ENVIRONMENT (8/09/13)
EXTENSIVE CORRESPONDENCE STILL RESULTS IN A WARNING LETTER During the time frame of March 25, 2013 through April 3, 2013 the FDA inspected Promed Exports Private Limited located at Promed Exports Private Limited, Khera Nihla Village, Tehsil Nalagarh, Solan District, Himachal Pradesh, 174101, … [Read more...]
FDA ISSUES WARNING LETTER FOR CLINICAL SUPPLY MANUFACTURING FACILITIES — FEBRUARY 10, 2011
Formatech, Inc Receives Warning Letter at Facility Manufacturing Clinical Trial Materials Comment: Clinical Supply Manufacturing (CMO) facilities are not customarily audited when they produce Phase 1, Phase 2 or Phase 3 Clinical Trial materials. A CMO would not typically receive its initial FDA audit until it requests its Pre-Approval Inspection (PAI) for a new drug. … [Read more...]
