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
USFDA warning letter: USV’s multiple manufacturing units
Posted on04 Apr 2017
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In a warning letter dated 10 March 2017, FDA cites USV for issues related to sterility testing for its products and data... 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
Frontida BioPharm received US FDA warning letter
Posted on28 Aug 2016
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USFDA sends the warning letter to Frontida BioPharm’s two manufacturing units, due to discrepancies in records related to manufacturing practices. FDA stated... 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
Sri Krishna Pharma received USFDA warning for cGMP norm violations
The Hyderabad-based Sri Krishna Pharmaceuticals has been warned by US health regulator for violations of good manufacturing practices at its facility, including... Read More
Alkem gets 8 observations from UKMHRA for Taloja plant
Posted on01 Apr 2016
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The Medicines and Healthcare Products Regulator Agency (UKMHRA) had conducted an inspection at the company’s facility at Taloja earlier this month with... Read More