Sun Pharma’s got clearance For Halol Facility From US Regulator
Sun Pharma received the EIR or Establishment Inspection Report from the US Food and Drug Administration (FDA) for its Halol facility in... Read More
USFDA warning letter for Jinan Jinda’s Zhangqiu City, China facility
Posted on04 Apr 2017
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On 24 February, FDA warned Jinan Jinda following a three-day inspection of the company’s Zhangqiu City, China facility where it manufactures active... 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
Claris Injectables receives five 483s from US FDA for plant in Ahmedabad
Posted on31 Aug 2016
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Claris Injectables Ltd (CIL), a wholly-owned subsidiary of the Ahmedabad-based Claris Lifesciences Ltd, has received five 483s from the US Food &... Read More
Why USFDA issued warning letter to Unimark Remedies?
The US Food and Drug Administration (USFDA) has warned Mumbai-based Unimark Remedies Ltd for violating good manufacturing practices at its two plants... 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
Alembic Pharma gets USFDA observations for Panelav plant
Drug firm Alembic Pharmaceuticals today said it has received four observations from the US health regulator after the inspection of Panelav facility.... Read More