FDA Inspection 1295002 — APL HEALTHCARE LIMITED
The FDA completed an inspection of APL HEALTHCARE LIMITED on Dec 17, 2025 in Tirupati. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 17, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tirupati (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1222 | 21 CFR 211.67(b)(4) | Cleaning SOPs/equipment identification |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |