By: IPP Bureau
Last updated : July 29, 2024 5:45 pm
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
Indoco Remedies gets 7 observations from USFDA for Plant 2 and 3 at Goa
The United States Food and Drug Administration (USFDA) had inspected Company's manufacturing facilities at Plant II (Sterile) and Plant III located at Goa ("Facility") from July 16, 2024 to July 26, 2024. On conclusion of the inspection, the Company received 7 (seven) observations in Form 483.
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe.
Successful completion of USFDA inspection at Alembic Pharmaceuticals’ Oral Solid Formulation facility (F-I) at Panelav
Alembic Pharmaceuticals Ltd has successfully completed the United States Food and Drug Administration (USFDA) inspection for its Oral Solid Formulation Facility (F-I) located at Panelav. This was a scheduled GMP inspection and was successfully completed without any Form 483 observation. The inspection was conducted from 17th July, 2024 to 26th July, 2024.