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FDA FORM 483
U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plantThe U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January inspection. Find...- USFDA issues Form-483 with two observations for Lupin's Nagpur plantLupin's Nagpur facility has received two observations from the USFDA through Form-483 due to violations of the Food Drug and Cosmetic (FD&C...
- 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 Unit
- Indoco Remedies receives EIR from USFDAIndoco Remedies got "establishment inspection report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the ...
- 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...
- Dr Reddy's gets 4 observations from USFDA for Srikakulam plant"The audit of our API Srikakulam Plant (SEZ), Andhra Pradesh, by the USFDA, has been completed on October 25, 2019. We have been issued a F...
- 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.
- USFDA concludes inspection of Unichem Lab's Roha facilityThe inspection was a post-approval inspection and successfully concluded.
- Aurobindo Pharma drops 5% on USFDA observationsShares of Aurobindo Pharma declined to Rs 605.90.
- 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...
- 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.
- 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...
- Aurobindo Pharma gains 2% as USFDA grants VAI to Hyderabad Unit IV; ends flatThe classification suggested that the matter has not escalated to the extent of slapping warnings letter or import alert.
- 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," ...
- 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...
- USFDA inspects Cadila Healthcare's Moraiya facility"USFDA inspected company's Moraiya facility from February 6, 2017 to February 15, 2017. At the end of the inspection no observation (483) i...
- USFDA made 9 observations post Halol unit inspection: Sun PharmaThe United States Food and Drug Administration (USFDA) inspected the Halol facility from November 17, 2016 through December 1, 2016, Sun Ph...
- 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...
- USFDA issues 6 observations post Indoco's Goa plant inspectionThe United States Food and Drug Administration (USFDA) inspected the company's Goa Plant II from August 31, 2016 to September 4, 2016, Indo...
- 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.
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