Biological E. Limited
Form 483 issued October 8, 2021 · Medchal, India
- Inspection
- Sep 28 – Oct 8, 2021
- Investigator
- Yvins Dezan
- Observations
- 6
- Pages
- 9
- FEI number
- 3008377265
In short: On October 8, 2021, FDA issued a Form 483 with 6 observations to Biological E. Limited in Medchal, Telangana (FEI 3008377265) after an inspection that ran Sep 28 – Oct 8, 2021. The investigator was Yvins Dezan. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Equipment and utensils are not cleaned, maintained, and sanitized to prevent malfunction and contamination that would…
- 04
The written stability testing…
This inspection in context
Yvins Dezan
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmBiological E. Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biological E. Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Biological E. Limited?
Yvins Dezan is named on this Form 483, for the inspection of Sep 28 – Oct 8, 2021. Each investigator has a profile showing what they cite most.
When was Biological E. Limited inspected by FDA?
The inspection ran Sep 28 – Oct 8, 2021, and the Form 483 is dated October 8, 2021.
How do I get the full Form 483 for Biological E. Limited?
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.