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
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
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
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
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
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