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FORM FDA 483
US FDA finds quality control, equipment issues at Alembic Pharma unitEarlier this month, the US drug regulator had issued a ‘Form 483’ to the facility of the drug company with five observations.19 Feb, 2021, 03.56 PM IST- Shilpa Medicare shares hit lower circuit after USFDA observations for Telangana unitThe US Food and Drug Administration (USFDA) issued form 483 with 15 observations to the company’s Jadcherla Unit26 Feb, 2020, 01.23 PM IST
- Indoco Remedies receives EIR from USFDAIndoco Remedies got "establishment inspection report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the ...26 Nov, 2019, 12.13 PM IST
- USFDA finds several violations in Aurobindo sterile injections unitFDA investigators have observed violations in sterilisation process to prevent microbial contamination and shortcomings in facility managem...23 Nov, 2019, 11.11 AM IST
- Inspection of Unichem's Kolhapur facility by USFDA completed without observationsThe inspection was a CGMP surveillance and pre-approval inspection and was successfully concluded without any FDA Form 483 issued.20 Sep, 2019, 04.22 PM IST
- USFDA concludes inspection of Unichem Lab's Roha facilityThe inspection was a post-approval inspection and successfully concluded.13 Sep, 2019, 03.41 PM IST
- Aurobindo Pharma drops 5% on USFDA observationsShares of Aurobindo Pharma declined to Rs 605.90.14 Jun, 2019, 04.02 PM IST
- Sun Pharma receives 483 for Baska facility, co says responded to USFDAAt the conclusion of the inspection, the US FDA issued a Form 483, with one observation for which the Company has submitted the response to...25 Mar, 2019, 06.27 PM IST
- USFDA completes Biocon's Telangana plant inspectionThe inspection was concluded without any observations and no Form 483 was issued, the company said.17 Dec, 2018, 12.31 PM IST
- USFDA conducting inspection of Mohali plant: Sun PharmaThe inspection by the United States Food and Drug Administration (USFDA) started on September 10, 2018 and is ongoing, Sun Pharma said in a...11 Sep, 2018, 09.24 PM IST
- Sun Pharma gets 6 observations by USFDA for its Halol facility"At the conclusion of the inspection, the agency issued a Form 483, with six observations," it added.07 Sep, 2018, 05.25 PM IST
- USFDA completes inspection at Caplin Point Lab's sterile injectable facility in Tamil Nadu"The United States Food and Drug Administration (USFDA) has conducted an inspection at our sterile injectable site (CP-IV) located at Gummu...07 Sep, 2018, 12.16 PM IST
- Strides Shasun gets 3 observations from USFDA for Bangalore plant"The formulations facility in Bangalore was recently inspected by the US FDA. The company has been issued a Form 483 with 3 observations," ...29 May, 2017, 11.23 AM IST
- Lupin gets three observations from USFDA for Goa plantAs per the USFDA, observations are made in Form 483 when investigators feel that practices in the facility are such that products may becom...28 Apr, 2017, 11.12 PM IST
- FDA issues observations post Sun Pharma Halol plant inspectionThe approval of several of Sun's key drugs in the United States, the drugmaker's biggest market, depends on the clearance on its Halol plan...07 Dec, 2016, 03.03 PM IST
- USFDA completes Wockhardt's Nalagarh facility inspectionWockhardt, which has been under the USFDA scanner, today said that United States health regulator has completed inspection of its facility.24 Jul, 2015, 05.46 AM IST
- Ranbaxy's Toansa, Mohali plants under US FDA scanner for manufacturing practicesThe Toansa plant is crucial for Ranbaxy as about 70% of APIs used in its formulations are said to be manufactured there.17 Jul, 2013, 04.00 AM IST
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