FORM FDA 483
Biocon shares fall as USFDA issues Form 483 for Bengaluru facilityBiocon said that the observations are procedural in nature.
- Shilpa Medicare shares hit lower circuit after USFDA observations for Telangana unit
The US Food and Drug Administration (USFDA) issued form 483 with 15 observations to the company’s Jadcherla Unit
- Indoco Remedies receives EIR from USFDA
Indoco 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 unit
FDA investigators have observed violations in sterilisation process to prevent microbial contamination and shortcomings in facility managem...
- No data integrity or repeat observations in the Form 483 we received: Kedar Upadhye, Cipla
We are in the process of drafting a very robust response to each of the observations in the Form 483.
- Inspection of Unichem's Kolhapur facility by USFDA completed without observations
The 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 facility
The inspection was a post-approval inspection and successfully concluded.
- Aurobindo Pharma drops 5% on USFDA observations
Shares of Aurobindo Pharma declined to Rs 605.90.
- Sun Pharma receives 483 for Baska facility, co says responded to USFDA
At the conclusion of the inspection, the US FDA issued a Form 483, with one observation for which the Company has submitted the response to...
- Aurobindo Pharma jumps 5% on reports of USFDA clearing Unit-4 facility
Shares of Aurobindo Pharma opened at Rs 752.90 on BSE against its previous closing of Rs 748.80.
- Biocon slips over 2% on 6 USFDA observations
US health regulator issued six observations in Form 483 after pre-approval inspection of its insulin drug substance manufacturing facility ...
- Biocon gets 6 observations from USFDA after inspection of its Bengaluru plant
Biocon is confident of addressing these expeditiously and remains committed to global standards of quality and compliance, the statement ad...
- Can USFDA all-clear for Duvvada earn Dr Reddy’s stock a rerating?
The Duvvada news has lifted a big overhang from the stock, said Edelweiss Securities.
- USFDA completes Biocon's Telangana plant inspection
The inspection was concluded without any observations and no Form 483 was issued, the company said.
- USFDA inspection of Biocon's drug substance unit at Bengaluru complete
The week-long audit concluded without any observations and no Form 483 was issued, it added.
- Strides Pharma drops 3% on USFDA observation for Bengaluru plant
The observations are not material in nature, the company said.
- USFDA conducting inspection of Mohali plant: Sun Pharma
The 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...
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