FDA Inspection 1172981 — Heliora Laboratories Pty Ltd.
The FDA completed an inspection of Heliora Laboratories Pty Ltd. on Jun 17, 2022 in Osborne Park. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 17, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Osborne Park (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |