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About 808 results for "Fda Good Manufacturing Practices"

FDA Issues Draft Data Integrity Guidance For Current Good Manu...

, the U.S. Food and Drug Administration (FDA) issued draft guidance titled Data Integrity and Compliance with CGMP Guidance for Industry (the Draft Guidance). Noting that the FDA has increasingly observed current good... By: King JD Supra, 1 week ago

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Wet Original® Personal Lubricant Receives FDA 510(k) Medical Device Clearance from Food and Drug Administration

Wet Original® meets FDA requirements for good manufacturing practice, labeling and prohibitions against misbranding and adulteration VALENCIA, Calif.--(BUSINESS WIRE)-- Trigg Laboratories is proud to announce that its Wet Original ® Personal ...
 CNBC2 weeks ago Wet Original Personal Lubricant Receives FDA 510(k) Medical Device Clearance From Food And Drug Administration  Packaging Network1 week ago Patent Issued for Methods of Treatment Using Alpha-1-Antitrypsin Compositions (USPTO 9320783)  Pharmacy Choice1 week ago
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Issues raised by US FDA for Pithampur unit resolved: Glenmark Pharma

The plant had received Form 483 observations for its current good manufacturing practices at the plant
 Business Standard1 month ago

Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Extension of Comment Period

Notification; extension of comment period. Citation: "81 FR 28083" Document Number: "Docket No. FDA -2015-N-4602" Page Number: "28083" "Notices" SUMMARY: The Food and Drug Administration ( FDA or we) is extending the comment period ...
 Equities.com2 weeks ago

US FDA warns Sri Krishna Pharma for CGMP rule violations

The Hyderabad-based Sri Krishna Pharmaceuticals has been warned by US health regulator for violations of good manufacturing practices at its facility, including data integrity issues.In a warning let...
 Business Line1 month ago

Capsugel subsidiary flagged by Swedish regulator for GMP failures

Dive Brief: The Swedish Medical Products Agency (MPA) will withdraw the E.U. good manufacturing practice (GMP) certificate from a subsidiary of major CRO Capsugel, after finding two critical and seven major deficiencies at the Bend, Oregon site. ...
 BioPharma Dive5 days ago

China FDA slams 3 drugmakers on manufacturing lapses

China FDA has ordered 3 drugmakers to recall certain products off the shelf in the latest effort to enforce good manufacturing practices (GMP) on the firms suspected of sending medicines to the market that failed origin, labelling, data and quality ...
 FiercePharma2 weeks ago

The Devil's in the Details of New Good Manufacturing Practices Rules

21 CFR 117 is must reading, not only for food safety but production efficiency and a tighter supply chain. By Kevin T. Higgins, Managing Editor May 05, 2016 The Bible is a mashup of two testaments that aren't always in sync. While one ...
 FoodProcessing.com2 weeks ago

FDA Issues Warning Letter to German API Manufacturer

FDA issued a warning letter to BBT Biotech GMBH, a Germany-based API manufacturer. The warning letter, issued on May 16, 2016, cited the company for failing to comply with current good manufacturing practice for APIs. During inspection of the ...
 PharmTech.com5 hours ago FDA Issues Warning Letter to Repackaging Facility  PharmTech.com2 weeks ago Recent FDA warning letters cite seafood, dairy, soybean firms  Before It's News3 weeks ago USFDA issues warning letter to Emcure Pharmaceuticals  Economic Times2 months ago

AllCells Introduces CliniCells Clinical Grade Products for Further Manufacturing of Allogeneic Cell Therapies

ALAMEDA, Calif.--( BUSINESS WIRE )--AllCells, LLC, (the company) today announced registration of its Alameda, CA facilities with the US-FDA enabling the company to immediately provide clinical grade products to customers developing cell therapies ...
 Business Wire6 days ago AllCells Introduces CliniCells? Clinical Grade Products for Further Manufacturing of Allogeneic Cell Therapies  Pharmacy Choice6 days ago AllCells, LLC Introduces CliniCells Clinical Grade Products For Further Manufacturing Of Allogeneic Cell Therapies  BioSpace6 days ago
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