FDA Inspection
Jubilant Cadista PharmaceuticalsJubilant Cadista Pharmaceuticals – FDA Inspection, Jan 15, 2025
Record Details
This FDA Inspection record concerns Jubilant Cadista Pharmaceuticals, with an inspection on January 15, 2025, issued by the Philadelphia District Office, covering human drugs.
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ID · 5b258395-a5e1-464c-948d-f9ba4d41d146
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1257696
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.110(d)Rejected in-process materials not quarantined
- 21 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- FDCA 582(b)(4)Systems in place to comply with verification requirements
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Other FDA inspections of Jubilant Cadista Pharmaceuticals
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 4, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2017 | Not classified | Philadelphia District Office |
Other documents for Jubilant Cadista Pharmaceuticals
- FDA Inspection 1064090 - 2018-05-04
- FDA Inspection 1004522 - 2017-03-08
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