FDA Inspection 1220834 — Macleods Pharmaceuticals Limited
The FDA completed an inspection of Macleods Pharmaceuticals Limited on Oct 20, 2023 in Tehsil Baddi, District Solan. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 20, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tehsil Baddi, District Solan (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |