BIOCON GENERICS INC
Form 483 issued February 2, 2022 · Cranbury, New Jersey
- Inspection
- Jan 24 – Feb 2, 2022
- Observations
- 3
- Pages
- 5
- FEI number
- 3014086465
In short: On February 2, 2022, FDA issued a Form 483 with 3 observations to BIOCON GENERICS INC in Cranbury, New Jersey (FEI 3014086465) after an inspection that ran Jan 24 – Feb 2, 2022. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Questions about this 483
What did FDA find at BIOCON GENERICS INC?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
When was BIOCON GENERICS INC inspected by FDA?
The inspection ran Jan 24 – Feb 2, 2022, and the Form 483 is dated February 2, 2022.
How do I get the full Form 483 for BIOCON GENERICS INC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.