Drug factory · FDA FEI 3003204330
FDC Limited
B-8, MIDC Industrial Area, Waluj, , Chhatrapati Sambhajinagar, India
No problems found at FDA's last inspection, Feb 12, 2023.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2012: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ciprofloxacin | Makes it and tests it | Leading Pharma, LLC | 69315-308 |
| Dorzolamide | Makes it and tests it | FDC Limited | 55545-1008 |
| Dorzolamide and Timolol | Makes it and tests it | FDC Limited, Leading Pharma, LLC | 55545-1007, 69315-305 |
| Latanoprost | Makes it and tests it | FDC Limited | 55545-1010 |
| Latanoprost Acid | Makes it and tests it | Rising Pharma Holdings, Inc. | 64980-516 |
| Ofloxacin | Makes it and tests it | FDC Limited, Rising Pharma Holdings, Inc. | 55545-1003, 64980-515 |
| Pilocarpine | Makes it | Leading Pharma, LLC | 69315-314, 69315-315, 69315-316 |
| Timolol | Makes it and tests it | FDC Limited, Rising Pharma Holdings, Inc. | 55545-1000, 55545-1001, 64980-513 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 12, 2023 | No problems found | Drug Quality Assurance | — |
| Aug 16, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
| Jul 1, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 6, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 21, 2012 | 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.
Aug 16, 2018 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures and laboratory control mechanisms are not followed. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Acceptance criteria for sampling & testing 21 CFR 211.165(d)
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release. - Data secured in course of each test 21 CFR 211.194(a)(4)
Laboratory records do not include a complete record of all data secured in the course of each test, including all spectra from laboratory instrumentation, properly identified to show the lot tested and drug product tested. - Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
Complaint records are deficient in that they do not include the findings of the investigation and follow-up. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Registered with FDA for: analysis; label; manufacture; pack.