BIOCON GENERICS INC
Form 483 issued September 8, 2020 · Cranbury, New Jersey
- Inspection
- Aug 25 – Sep 8, 2020
- Investigators
- Annet R. Rajan· Yvins Dezan
- Observations
- 3
- Pages
- 5
- FEI number
- 3014086465
In short: On September 8, 2020, FDA issued a Form 483 with 3 observations to BIOCON GENERICS INC in Cranbury, New Jersey (FEI 3014086465) after an inspection that ran Aug 25 – Sep 8, 2020. The investigators were Annet R. Rajan and Yvins Dezan. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Annet R. Rajan
16 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmBIOCON GENERICS INC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BIOCON GENERICS INC?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected BIOCON GENERICS INC?
Annet R. Rajan and Yvins Dezan are named on this Form 483, for the inspection of Aug 25 – Sep 8, 2020. Each investigator has a profile showing what they cite most.
When was BIOCON GENERICS INC inspected by FDA?
The inspection ran Aug 25 – Sep 8, 2020, and the Form 483 is dated September 8, 2020.
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.