Biological E. Limited
Form 483 issued April 26, 2024 · Medchal, India
- Inspection
- Apr 15 – Apr 26, 2024
- Investigator
- Cynthia Jim
- Observations
- 6
- Pages
- 5
- FEI number
- 3008377265
In short: On April 26, 2024, FDA issued a Form 483 with 6 observations to Biological E. Limited in Medchal, Telangana (FEI 3008377265) after an inspection that ran Apr 15 – Apr 26, 2024. The investigator was Cynthia Jim. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.113 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
When errors occurred or a production batch failed to meet specifications, you did not take appropriate…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
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 211.113
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, laboratory controls and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Biological E. Limited?
Cynthia Jim is named on this Form 483, for the inspection of Apr 15 – Apr 26, 2024. Each investigator has a profile showing what they cite most.
When was Biological E. Limited inspected by FDA?
The inspection ran Apr 15 – Apr 26, 2024, and the Form 483 is dated April 26, 2024.
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.