Drug factory · FDA FEI 3011786267
LIFEPharma FZE
Near Round-About 13, Plot No MO0502, Dubai, United Arab Emirates
Problems found, fixed voluntarily at FDA's last inspection, Nov 24, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2022: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Doxepin | Makes it | Leading Pharma, LLC | 69315-158, 69315-159, 69315-160 +3 |
| Frovatriptan | Makes it | Leading Pharma, LLC | 69315-157 |
| Oxybutynin | Makes it and tests it | Leading Pharma, LLC | 69315-182 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 24, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
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 24, 2022 inspection
- Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
Registered with FDA for: analysis; manufacture; pack.