Drug factory · FDA FEI 3000164186
Bio-Technology General (Israel) Ltd.
Kiryat Malachi, Kiryat Malachi, Israel
Problems found, fixed voluntarily at FDA's last inspection, Jul 11, 2019.
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 2008: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Pegloticase | Makes the active ingredient | Savient Pharmaceuticals, Inc. | 54396-801 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 11, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 1, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 10, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 27, 2008 | 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.
Aug 1, 2013 inspection
- Drug products-sampling procedures/specifications 21 CFR 211.160(b)(3)
Laboratory controls do not include a determination of conformance to appropriate specifications for drug products. - Lack of or inadequate procedures 21 CFR 820.100(a)
Procedures for corrective and preventive action have not been established. - Process control procedures, Lack of or inadequate procedures 21 CFR 820.70(a)
Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.