ESTABLISHMENT INSPECTION REPORT
China constructed nine buildings in Lapcha-Limi region of Nepal: Report
The development came to light during an inspection of the Lapcha-Limi region of Nepal's remote Humla region from August 30 to September 9 b...
Inquiry committee instituted to establish cause behind Vizag crane mishap: Rajnath Singh
The new crane was erected at the Hindustan Shipyard about two years ago but was not yet commissioned for regular operations due to change i...
Biocon gets establishment inspection report from USFDA for Bengaluru plant
The EIR has been closed with a voluntary action indicated (VAI) classification for the observations, it added. As per the USFDA, a VAI mean...
Dr Reddy's gets USFDA inspection closure report for Srikakulam plant
The US Food and Drug Administration (USFDA) had issued a warning letter to the facility in November, 2015, after inspecting it in 2014.
Natco Pharma gets EIR from USFDA for Telangana facility
The United States Food and Drug Administration (USFDA) had conducted pre-approval inspection at the company's drug formulations facility ...
USFDA clears four Indian manufacturing plants in 10 days
India’s leading drug companies have had their manufacturing facilities cleared in the last 10 days by the US Food and Drug Administration (...
Cadila Healthcare gets EIR from USFDA for its Ahmedabad facility
The company's topical manufacturing facility at Ahmedabad has received an EIR from the United States Food and Drug Administration (USFDA) s...
Cipla announces closure of USFDA inspection at Patalganga facility
Cipla recently announced the closure of inspection by United States Food and Drug Administration (USFDA) at the Patalganga manufacturing fa...
Strides arm receives EIR for its US facility
The facility is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations w...
Indoco Remedies receives EIR from USFDA
Indoco Remedies got "establishment inspection report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the ...
Strides Pharma gets USFDA inspection report for Alathur unit with no adverse observations
The company said the company's formulations unit in Alathur was inspected by the US Food and Drug Administration (USFDA) in August without ...
Zydus Cadila gets EIR from USFDA for Ankleshwar facility
The company's active pharmaceutical ingredient (API) manufacturing facility located at Ankleshwar (unit 1), Gujarat has received an Establi...
Cipla announces closure of USFDA inspection at Bengaluru facility
The company had earlier said that USFDA issued seven observations after conducting a routine 'CGMP inspection' at Cipla's API manufacturing...
Warning letter woes: Dr Reddy's expects FDA inspection of AP plant by year-end
USFDA had issued warning letter in November 2015 relating to Current Good Manufacturing Practice deviations at DR Reddy's API manufacturing...
Have received inspection closure report from USFDA for Duvvada facility: Dr Reddy's
"We have received a written communication about the issuance of establishment inspection report (EIR) for FTO VII", said Dr Reddy's.
Dr Reddy's Labs gets EIR from USFDA for Srikakulam unit
The EIR from the United States Food and Drug Administration (USFDA) indicates closure of the audit of the plant, Dr Reddy's Labs said in a ...
Marksans Pharma gets EIR from USFDA for its Goa facility
As per the USFDA, after the completion of an inspection of a facility, an EIR is issued to a company detailing inspectional findings.
Orchid Pharma gets EIR from USFDA for its Alathur facility
Orchid Pharma today said it has received establishment inspection report (EIR) from the US health regulator for its Alathur facility in Tam...
Dr Reddy's gets EIR for 2 facilities
The company has received EIR from USFDA for its formulations manufacturing facility at Srikakulam unit II, Dr Reddy's said in a filing to B...
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