Drug factory · FDA FEI 3004495158
Micro Labs Limited
Plot No 16 & 24, Veerasandra Industrial Area Electronic City Phase 2, Bengaluru, India
Problems found, fixed voluntarily at FDA's last inspection, Feb 7, 2025.
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 2015: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amoxicillin | Makes it, tests it, packages it and labels it | Micro Labs Limited | 42571-233, 42571-234 |
| Amoxicillin and Clavulanic Acid | Makes it, tests it, packages it and labels it | Medsource Pharmaceuticals, Micro Labs Limited | 45865-227, 45865-230, 42571-160 +2 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jan 24, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 16, 2018 | No problems found | Drug Quality Assurance | — |
| Dec 18, 2015 | 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.
Feb 7, 2025 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures and laboratory mechanisms are not recorded and justified. - 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 components and drug products conform to appropriate standards of identity, strength, quality and purity. - 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. - 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.
Registered with FDA for: analysis; label; manufacture; pack.