Dr. Reddy’s Nets A Form 483 for Equipment and Facility Cleanliness
Dr. Reddy’s Laboratories Telangana, India, facility received yet another FDA Form 483 after an Oct. 19-27 inspection resulted in a 25-page report detailing powdery residue in multiple places on floors and equipment, pointing to a lack of cleaning and lack of equipment maintenance, among other lapses.
Investigators reported that they found “thick deposition and layers of off-white, pale yellowish to yellowish and black to brownish powdery materials” on a platform supporting the rapid mixture granulator (RMG). Further, the report states that the non-dedicated RMGs used for finished drug products “have not been cleaned and verified for cleanliness underneath the mounted platform areas since their installation several years ago.”
The company has received multiple 483s in the past, for a lack of microbiological testing, deficient air supply in asceptic areas and customer complaints for out of specification results on purchased products. FDAnews records show the firm receiving 12 Form 483s since 2012, including reports for company facilities in several locations in India as well as in New York, and Louisiana.
Read the Form 483 here.
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