Drug factory · FDA FEI 3005669319
Encube Ethicals Limited
Plot No C-1 Madkaim Industrial Estate, Ponda, India
Problems found, fixed voluntarily at FDA's last inspection, Jun 17, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2012: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 17, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 11, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| Aug 27, 2015 | No problems found | Drug Quality Assurance | — |
| Mar 23, 2012 | No problems found | 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.
Jun 11, 2019 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed and documented at the time of performance. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. - Instruments, apparatus, et. al. not meeting specs 21 CFR 211.160(b)(4)
The use of instruments not meeting established specifications was observed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - 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. - Complaints reviewed by Quality Control Unit 21 CFR 211.198(a)
Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications, a determination as to the need for an investigation of any unexplained discrepancy and explaining the reasons for the failure of the batch or any of its components to meet specifications. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; label; manufacture; pack.