What are the difference between FDA 483 and Warning Letter?
Posted on27 Mar 2020
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483 observation or FDA 483 and warning letter seems to be same, nut there is difference between the FDA form 483 and... Read More
USFDA shooting up warning letters to marketers for Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Center for Drug Evaluation and Research (CDER), of United States Food and Drug Administration have busy time in monitoring illogical claims made... Read More
US FDA issued warning letter to Glenmark for Baddi plant
Posted on21 Oct 2019
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The US Food and Drug Administration has issued a warning letter to Glenmark Pharmaceutical Ltd’s manufacturing plant in Baddi, Himachal Pradesh, the company said... Read More
Strides Pharma received USFDA warning letter for significant violations of CGMP regulations for finished pharmaceuticals
The U.S. Food and Drug Administration (FDA) inspected drug manufacturing facility, Strides Pharma Science Limited at Unit-II, R. S. No.: 32, 33... Read More
US FDA warning letter: Repackers distributing API for violations of cGMP violation requirements
Posted on07 Jul 2019
Tags483, 483 OBSERVATION, 483 observations, API industry, fda 483 observation, form 483 observation, USFDA warning letter
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The US Food and Drug Administration (FDA) has issued warning letters to three repackers of active pharmaceutical ingredients (API), B&B Pharmaceuticals, Inc.,... Read More
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