Pharmaceutical Quality Assurance

USFDA issues six observations after inspection of Biocon’s Malaysian arm manufacturing facility

As per the US health regulator, an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has…

Biocon Malaysia insulin aspart plant hit with 6 observations by US FDA – Ultra News

Lupin gets US FDA warning letter for Somerset plant Lupin Ltd, one of the world’s largest generic drug makers, today said it received a warning…

US FDA issues Form 483 to Lupin’s Goa plant – Express Pharma

The United States Food and Drug Administration (FDA) has recently issued Form 483 to Lupin’s Goa plant. The inspection was carried out from 6th to…

Lupin in focus: ET NOW accesses Form 483 issued to Goa facility | Business News

Lupin Goa plant gets 7 observations from US FDA · ET NOW accesses Form 483 issued to the company’s Goa facility.

Lupin’s Goa plant gets 7 observations from USFDA, firm unperturbed | Business Standard News

The plant was again re-inspected in the beginning of 2019, and the FDA had then issued a ‘form 483‘ with two or more observations.

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.