Drug factory · FDA FEI 3004039360
OLIC (Thailand) Limited
166 Moo 16, Bangpa-In Industrial Estate, Udomsorayuth Rd, Bang Pa In, Thailand
No problems found at FDA's last inspection, Oct 28, 2022.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2014: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Methylene Blue Cation | Makes it | OLIC (Thailand) Limited | 15243-344 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 28, 2022 | No problems found | Drug Quality Assurance | — |
| Nov 22, 2018 | No problems found | Over-the-Counter Drug Evaluation | — |
| Nov 18, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| May 2, 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.
Nov 18, 2016 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - 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 specifications designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity. - Annual visual exams of drug products 21 CFR 211.170(b)
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Registered with FDA for: analysis; manufacture; repack.