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Home » Topics » Drugs » Inspections and Audits

Inspections and Audits
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Meeting Requests, Manufacturer Assessments for NDAs and BLAs Subject of Draft Guidances

September 21, 2023
The FDA has issued two draft guidances focused on requirements for drug and biological approvals — one on formal meetings and one on alternative methods the agency may use to assess manufacturing facilities named in an NDA or BLA. Read More

Warning Letter Cites Repackaging Company Safecor for Mixing Up Drugs

September 15, 2023
Safecor didn’t test incoming components such as water used to manufacture prescription drug products. Read More

Drug Repackaging Company Safecor Cited in Warning Letter for Mixing Up Drugs

September 13, 2023
A mix up that put a vitamin in a blister pack where a drug to prevent organ transplant rejection belonged is one of several violations the FDA cited in its warning letter to Safecor, a Columbus, Ohio, drug manufacturer and repackaging company. Read More

Unapproved Eye Drops Earn Drug Makers Eight Warning Letters, Two Import Alerts

September 12, 2023
The FDA has issued warning letters to eight companies — including CVS Health and Walgreens Boots Alliance — for manufacturing or marketing illegal, unapproved eye drops to treat pink eye, glaucoma and cataracts and other ophthalmic conditions. Read More

OTC Drugmaker Gets Warning Letter From FDA Record Review

September 11, 2023
The letter also notes that the company was put on an import alert July 17. Read More

FDA Record Review Results in Warning Letter for OTC Drugmaker

September 7, 2023
The FDA has exercised its new authority to use remote records reviews in lieu of certain types of GMP inspections, issuing a warning letter to Green Pharmaceutical of South Korea based on a review of records it requested on March 3. Read More

Quick Notes for Aug. 30, 2023

August 30, 2023
Our coverage spans a bone graft product that caused a tuberculosis infection, a subcutaneous cancer treatment, a warning letter for an eye drop manufacturer, 300 higher risk patients with a recalled Medtronic cardiac pump, and a lawsuit by Insulet against a competitor for intellectual property theft. Read More

Biocon Malaysia Plant Gets 483 for Sterility, Testing, Quality Control Issues

August 16, 2023
A July 10-20 FDA inspection of a Biocon manufacturing facility in Malaysia turned up eight observations including a repeat observation of failure to follow procedures that prevent microbiological contamination of drugs intended to be sterile, and inadequate review and investigation of failed batches. Read More

FDA Advances Fight Against DEG-EG Contamination With Multiple Warning Letters

August 11, 2023
The agency has updated its webpage on the issue with a statement from the CDER director. Read More

Multiple Warning Letters Advance FDA’s Fight Against DEG-EG Contamination

August 9, 2023
The FDA’s efforts to safeguard against the presence of diethylene glycol (DEG) ethylene glycol (EG) in drug products have resulted in the agency issuing 22 warning letters on the potentially lethal contaminant since March — and nine on the issue just this week. Read More

Form 483: Poor Aseptic Procedures and Dirty Bathrooms Get Iso-Tex Drugmaker Cited

August 3, 2023
The FDA slapped Iso-Tex with a Form 483 following a Jan. 30 – Feb. 10 inspection because the radiopharmaceutical manufacturer failed to prevent microbiological contamination of drug products at its Alvin, Tex., plant. Read More

Form 483: Lapses Identified at Catalent Facility Net Regeneron’s Eylea CRL

August 3, 2023
The FDA released a Form 483 from a May 4-12 inspection conducted at Catalent’s Bloomington, Ind., facility pointing to continuing woes for the plant and its customers, with observations of a lack of written production and process control procedures, inadequate equipment revalidation and inadequate cleaning. Read More
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