Biological E. Limited
Form 483 issued November 12, 2024 · Medchal, India
- Inspection
- Nov 4 – Nov 12, 2024
- Investigators
- Anastasia M. Shields· Clinton J. Lott
- Observations
- 2
- Pages
- 6
- FEI number
- 3008377265
In short: On November 12, 2024, FDA issued a Form 483 with 2 observations to Biological E. Limited in Medchal, Telangana (FEI 3008377265) after an inspection that ran Nov 4 – Nov 12, 2024. The investigators were Anastasia M. Shields and Clinton J. Lott. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biological E. Limited?
FDA listed 2 observations on this Form 483, mostly about 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?
Anastasia M. Shields and Clinton J. Lott are named on this Form 483, for the inspection of Nov 4 – Nov 12, 2024. Each investigator has a profile showing what they cite most.
When was Biological E. Limited inspected by FDA?
The inspection ran Nov 4 – Nov 12, 2024, and the Form 483 is dated November 12, 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.