USFDA issues EIR to Baddi facility of Aarti Drugs’ arm

30 Jul 2024 Evaluate

U.S. Food and Drug Administration (USFDA) has issued Establishment Inspection Report (EIR) to Aarti Drugs’ subsidiary -- Pinnacle Life Science’s manufacturing facility located at Baddi, Himachal Pradesh.

USFDA conducted inspection from April 16, 2024 to April 22, 2024. On conclusion of the inspection, the company had received 5 inspectional observations in Form 483, where none of the observations are related to Data Integrity.

Aarti Drugs is engaged in the manufacturing of Active Pharmaceutical Ingredients (APIs), Pharma Intermediates, Specialty Chemicals and also produces Formulations with its wholly-owned subsidiary - Pinnacle Life Science.

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