Case analysis: 483 observations – Data Integrity issues in Aurobindo Pharma’s finished dosage formulation plant
Posted on17 Jun 2019
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The US Food and Drug Administration has pointed out data integrity lapses at Aurobindo Pharma Limiteds finished dosages plant at Bachupally, Telengana... Read More
DRL’s API plant in Medak and Biocon’s Malaysian Plant got USFDA 483 observations
Posted on19 Mar 2018
Tags483, 483 OBSERVATION, 483 observations, fda 483 observation, form 483 observation, usfda 483 form
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Dr Reddy’s Laboratories received the US Food and Drug Administration has issued a Form 483 with four observations after inspecting its active... Read More
Wockhardt’s Ankleshwar plant received USFDA warning letter over data integrity issues
Posted on05 Jan 2017
Tags483, 483 OBSERVATION, 483 observations, FORM 483, form 483 observation, USFDA warning letter, Wockhardt
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US Food and Drug Administration (USFDA) has issued a warning letter to Wockhardt’s Ankleshwar plant for data integrity issues, destruction of records... Read More
Wockhardt’s indirect subsidiary, CP Pharmaceuticals, UK received USFDA warning letter for GMP violation
Posted on29 Nov 2016
Tags483 OBSERVATION, 483 observations, fda 483 observation, FORM 483, form 483 observation, USFDA warning letter
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Wockhardt’s indirect subsidiary, CP Pharmaceuticals, UK received USFDA warning letter for GMP violoation Wockhardt Ltd has received a warning letter from the... Read More
Sun Pharma received 483 observation for Mohali Plant
Posted on25 Nov 2016
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Reason for 483 observation issued: Deviation from manufacturing standard About Plant: The Mohali facility, which belonged to Ranbaxy Laboratories Ltd, has been... Read More
One more Indian Plant received USFDA observations: Alkem’s Daman Plant
Alkem Laboratories has received 13 observations from the US drug regulator for its manufacturing facility at Daman. This obervation comes as response... Read More
Is the FDA Form 483 is an all-inclusive list of every possible deviation from law and regulation?
Posted on08 Jun 2016
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No. Generally it does not include observations of questionable or unknown significance at the time of the inspection. There may be other... Read More
Glenmark receives 3 observations from USFDA for Indore plant
Posted on22 Apr 2016
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Glenmark Pharmaceuticals has received three observations from the US health regulator for its Pithampur, Indore (India) plant. The Pithampur plant was inspected... Read More
Cipla gets 483 observation for Indore unit
Indian drug maker Cipla Ltd. has been served 483 observations by the US FDA for its Indore-based manufacturing unit as part of an... Read More
What is Form 483 in regulatory affairs?
Posted on27 Nov 2014
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Dr Reddy’s Laboratories has received inspectional observations from the US Food and Drug Administration (FDA) for one of its active pharmaceutical ingredients... Read More