FDA Inspection 1243287 — Pharmaffiliates Analytics & Synthetics Pvt., Ltd.
The FDA completed an inspection of Pharmaffiliates Analytics & Synthetics Pvt., Ltd. on Jul 5, 2024 in Panchkula. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 5, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Panchkula (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |