OneSource Specialty Pharma Limited
Form 483 issued November 22, 2024 · Bengaluru, India
- Inspection
- Nov 14 – Nov 22, 2024
- Investigators
- Anastasia M. Shields· Clinton J. Lott
- Observations
- 3
- Pages
- 3
- FEI number
- 3005652193
In short: On November 22, 2024, FDA issued a Form 483 with 3 observations to OneSource Specialty Pharma Limited in Bengaluru, Karnataka (FEI 3005652193) after an inspection that ran Nov 14 – Nov 22, 2024. The investigators were Anastasia M. Shields and Clinton J. Lott.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Changes to written procedures are not drafted, reviewed and approved by…
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 firmOneSource Specialty Pharma Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at OneSource Specialty Pharma Limited?
FDA listed 3 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected OneSource Specialty Pharma Limited?
Anastasia M. Shields and Clinton J. Lott are named on this Form 483, for the inspection of Nov 14 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was OneSource Specialty Pharma Limited inspected by FDA?
The inspection ran Nov 14 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for OneSource Specialty Pharma 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.