Drug factory · FDA FEI 3005183272
Elysium Pharmaceuticals Ltd
253 to 256 and 258, Post: Dabhasa Taluka: Padra, Vadodara, India
Problems found, fixed voluntarily at FDA's last inspection, Jan 16, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2014: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Azathioprine | Makes it, tests it and labels it | Rising Pharma Holdings, Inc. | 16571-835 |
| Folic Acid | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 16571-881 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 16, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 10 |
| Jan 16, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 10 |
| Sep 8, 2017 | No problems found | Drug Quality Assurance | — |
| Sep 8, 2017 | No problems found | Drug Quality Assurance | — |
| Dec 26, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 26, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 16, 2023 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures are not recorded and justified. - Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures are not recorded and justified. - Identification of Persons Performing Significant Steps 21 CFR 211.188(b)(11)
The batch production and control records are deficient in that they do not include identification of persons each significant step in the operation. - Identification of Persons Performing Significant Steps 21 CFR 211.188(b)(11)
The batch production and control records are deficient in that they do not include identification of persons each significant step in the operation. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Plumbing System Defects 21 CFR 211.48(a)
The plumbing system contains defects that could contribute to the contamination of drug products. - Plumbing System Defects 21 CFR 211.48(a)
The plumbing system contains defects that could contribute to the contamination of drug products. - Cleaning SOP/inspection 21 CFR 211.67(b)(6)
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. - Cleaning SOP/inspection 21 CFR 211.67(b)(6)
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.
Registered with FDA for: analysis; label; manufacture; pack.