Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Warning letter (dated November 17, 2023) follows the FDA inspection at Cipla’s Pithampur, Indore
USFDA Inspected Indian drug manufacturer Kilitch facility in Mumbai (FEI 3011853060) in Oct 2023. USFDA
Natco Pharma (india) Kothur facility was inspected by USFDA (Investigators Pratik S. Upadhyay and Saleem
Natco Pharma (india) Kothur facility was inspected by USFDA in October 2023. The site (FEI
USFDA 483 / UCB Farchim SA/ June 2023 / Deficiencies in Method Transfer, Material receipt
Qvent post discusses the Regulatory guidances and Requirements for Electronic data controls and review, Data
USFDA 483 issued to UCB Farchim SA, Switzerland site (FEI 3005023799) is published by FDA.
Panacea Biotec, Baddi facility was inspected by USFDA in Oct 2023- investigators Sandra A Boyd
Spectrum Laboratories Inc, New Jersey, USA (FEI 2246824) was inspected by FDA investigators Sayyem H
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
