Search result for 'usfda form 483'

USFDA issues Form 483 with 7 observations to Natco Pharma's Chennai API unit after inspection. Details inside.

USFDA issues Form 483 with 4 observations to Lupin's Pithampur Unit-2 facility after inspection. Company working to resolve issues.

USFDA issues Form 483 with 8 observations to Aurobindo Pharma's Telangana unit. Company to respond within stipulated timelines.

Dr. Reddy's Laboratories receives a Form 483 with seven observations from the USFDA after an inspection of its Srikakulam plant in Andhra Pradesh.

USFDA issued a Form 483 with seven observations to Natco Pharma's Hyderabad facility after an inspection. Natco Pharma is committed to addressing the observations.

Glenmark Pharmaceuticals received five observations from the USFDA after an inspection of its Monroe plant. The observations are procedural and do not relate to data integrity. The company will...

Dr Reddy's Laboratories received two observations from the USFDA after an inspection of its API manufacturing plant in Telangana. The observations were issued in the form of a Form 483, which...

Dr Reddy's Laboratories received two observations from the USFDA following an inspection of its API facility in New York. The observations were related to Good Manufacturing Practices (GMP).

Emcure Pharmaceuticals received two observations from the USFDA after an inspection of its Pune-based API manufacturing facility. The company is addressing the observations and will respond to the...

USFDA issued a Form 483 with three observations to Gland Pharma's facility in Visakhapatnam after a pre-approval inspection for sterile APIs. The observations are procedural in nature and will be...

Dr Reddy's Laboratories received seven observations from the USFDA following an inspection of its Bollaram facility. The company will address the observations within the stipulated timeline.

Torrent Pharmaceuticals received a Form 483 with one observation from the USFDA after an inspection of its Pithampur manufacturing facility. The observation is procedural in nature and the company...

Dr Reddy's Laboratories has received an Establishment Inspection Report (EIR) from the USFDA for its formulations manufacturing units in Visakhapatnam, classifying the facilities to voluntary...

Cipla Ltd received a Form 483 from the USFDA for its Kurkumbh facility in Maharashtra, citing one inspectional observation. The company is committed to addressing the observation.

Marksans Pharma Ltd received five inspectional observations in Form 483 from the USFDA after an inspection of its Goa manufacturing facility. The company will address the observations within the...

USFDA issued Form 483 with 5 procedural observations to Torrent Pharma's Gujarat oral manufacturing facility. The observations were not related to data integrity.

Dr Reddy's Laboratories stock closed 5% lower after the USFDA issued three observations for its Hyderabad research facility. The company said it will address the issues within the stipulated timeline.