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Fda warning letter to sandoz



An Analysis Of FDA FY2016 Drug GMP Warning Letters

7.24.2018 | Logan Murphy
Fda warning letter to sandoz
An Analysis Of FDA FY2016 Drug GMP Warning Letters

This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area.

Irvine Stem Cell Treatment Center Center 4 USA API 12/31/2015.

Los Angeles 3 USA API 8/4/2016. Adamson Analytical Laboratories Inc.

Xinchange Pharmaceutical Factory Center 3 China Compounding pharmacy 8/5/2016. Zhejiang Medicine Co. Ltd.

Ltd. Cheng Fong Chemical Co. Center 3 China Drug product 9/15/2016.

Ko Da Pharmaceutical Company Limited Center 4 Taiwan Drug product 6/2/2016.

By Barbara Unger, Unger Consulting Inc.

People's Custom Rx and Clinical Care, LLC New Orleans 3 USA Compounding pharmacy 6/7/2016.

Center 4 India Compounding pharmacy 4/21/2016.

FDA Warns Sandoz, Dr. Reddy's Indian Sites Over Data Integrity

11.28.2018 | Logan Murphy
Fda warning letter to sandoz
FDA Warns Sandoz, Dr. Reddy's Indian Sites Over Data Integrity

Serious data integrity violations, including the backdating of records and failing to provide pertinent data to regulators, were included in warning letters for five manufacturing facilities from both Sandoz and Dr. Reddy's in India, according to the US Food and Drug Administration (FDA).

“A partially-completed document retrieved from the waste receptacle included handwritten notes about the condition of equipment observed during preventive maintenance. Your response did not sufficiently identify the scope of these practices at your facility,” FDA said. However, the corresponding official record did not include the same information.

Dr. Reddy’s Warning Letter Sandoz Warning Letter.

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FDA officials inspecting two of the generic drug manufacturer’s sites in Maharashtra, India in August 2014 noted some peculiar handling of batch documentation by Sandoz employees.

The company was also cited for failing to control access to some of its computer systems with passwords, and failing to explain discrepancies between the release of APIs and deviations that occurred, among other inconsistencies with media-fill records and batch records for drums used to hold intermediates during manufacturing.

Later on at the same site, FDA investigators found original preventive equipment maintenance work orders in trash bags.

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Momenta Pharmaceuticals Announces FDA Warning Letter to

12.29.2018 | Kayla Bishop
Fda warning letter to sandoz
Momenta Pharmaceuticals Announces FDA Warning Letter to

17, 2017 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that Sandoz's contracted fill/finish manufacturing partner, Pfizer, has received an FDA warning letter.

Pfizer has indicated that the warning letter does not restrict the production or shipment of the Glatopa 20 mg (glatiramer acetate injection) product that is currently marketed by Sandoz in the United States. (Nasdaq: MNTA ), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that Sandoz’s contracted fill/finish manufacturing partner, Pfizer, has received an FDA warning letter. 17, 2017 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc.

Sandoz GMP Warning Letter Is The Problem Documentation, Or

10.27.2018 | Aidan Jerome
Fda warning letter to sandoz
Sandoz GMP Warning Letter Is The Problem Documentation, Or

Executive Summary. Upper management at Novartis and Sandoz are responsible for repeated cGMP violations at three Sandoz plants, FDA suggests. The agency's warning letter, aimed at three sites in North Amercia, includes what may become new biolerplate instructions on drug shortages. Already Registered? Sign in.

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U.S. FDA warns Novartis on manufacturing violations at 2 India plants

9.26.2018 | Daniel Kendal
Fda warning letter to sandoz
U.S. FDA warns Novartis on manufacturing violations at 2 India plants

Novartis did not specify details of the warning. The FDA usually posts warning letters on its website a week after issuing them. The letter to Novartis was not posted as of 0600 ET on Wednesday. “Sandoz will continue to work closely with the FDA to ensure all observations are resolved to the agency's full.

Reuters Staff 2 Min Read.

Reporting by Zeba Siddiqui in Mumbai; Editing by Muralikumar Anantharaman.

Novartis already stated in July that it would shutter the Turbhe plant, where it made antibiotics and active pharmaceutical ingredients, by December 2016, as part of plans to optimize its global manufacturing network.

The FDA has banned more than 30 drug manufacturing plants in India since 2013, as it ramps up inspections of foreign facilities that supply to the United States. Several of India’s largest drugmakers have faced rebukes, hurting the reputation of the industry, an important supplier of cheap generics.

The FDA expressed its concerns to the company last year, and Novartis has been working on addressing them since, it said in a statement disclosing its quarterly results on Tuesday.

Sandoz will continue to work closely with the FDA to ensure all observations are resolved to the agency’s full satisfaction,” the company said, adding that no supply disruptions were expected.

Novartis did not specify details of the warning.