Pharmaceutical Quality Assurance

US FDA Concludes Inspection At Lupin’s Goa Facility With Seven Observations – Moneycontrol

Notably, Lupin’s Goa site, along with Unit 2 manufacturing plant in Pithampur, Indore had received US FDA’s warning letter in November 2017.

FDA Inspection Audit? What to Expect | Oberheiden P.C. – JDSupra

While Form 483 contains the inspector’s findings related to any potential violations of the Food, Drug & Cosmetic Act, it is not the inspector’s final …

FDA blasts Flagship-backed microbiome player’s ‘non-IND’ Covid-19 trial – Endpoints News

Kaleido was well aware of the FDA’s objections, according to the letter, which stated that inspector Kent Conforti had presented a Form 483 and …

UPDATED: Food or drug? FDA blasts Flagship-backed microbiome player’s ‘non-IND’ Covid …

“As Kaleido noted in its response to the Form FDA 483, whether an investigational article is a drug or a food depends on the intent…

FDA Details Observations At Stricken Jubilant Roorkee Facility – Generics Bulletin

… including for cleanliness, laboratory controls, control procedures and data management, according to a US FDA Form 483 that has just been unveiled.

Iris Recognition In Access Control Market Size, Trends, SWOT, PEST, Porter’s Analysis, For …

The report further more provides an in-depth analysis of the market growth, market size, and influential factors that affect the growth of the industry. The …

After the Recall: A Framework for Recovery – National Law Review

If problems are found during the inspection, the manufacturer will be given a Form FDA 483 which details the concerns identified during the inspection.

Fierce Pharma Asia—Samsung’s $205B investment; Moderna COVID vaccine impurities …

In its first publicly posted Form 483 in months, the FDA blasted Jubilant Generics for a slate of problems at the company’s facility in Haridwar,…

FDA blasts Toyobo for subpar particulate investigation and data integrity breaches | FiercePharma

Toyobo attempted to correct its ways in March when it submitted its response to a form 483, but the regulator still has concerns.

Most Common Reasons For FDA Form 483 Observations And Warning Letters In Medical …

Issues that are considered objectionable conditions or compliance violations by FDA inspectors are itemized in a Form 483 or a warning letter.