Drug factory · FDA FEI 3005999589
Lotus Pharmaceutical Co., Ltd. Nantou Plant
No. 30 Chenggong 1st Rd., Sinsing Village, Nantou City, Nantou County, Taiwan
Problems found, fixed voluntarily at FDA's last inspection, Apr 12, 2024.
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 2010: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Mefenamic Acid | Makes it | Misemer Pharmaceuticals, Inc. | 0276-0509 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 12, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| May 31, 2019 | No problems found | Drug Quality Assurance | — |
| Sep 22, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 4, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 16, 2012 | No problems found | Drug Quality Assurance | — |
| Feb 11, 2010 | 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.
Apr 12, 2024 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to fully investigate errors that have occurred. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Sep 22, 2017 inspection
- Drug products - samples representative, identified properly 21 CFR 211.160(b)(3)
Samples taken of drug products for determination of conformance to written specifications are not representative. - 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. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Registered with FDA for: analysis; label; manufacture; pack.