FDA Inspection 1110489 — MSN Laboratories Private Limited (Formulations Division, Unit-II)
The FDA completed an inspection of MSN Laboratories Private Limited (Formulations Division, Unit-II) on Nov 15, 2019 in Rangareddy District. 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
- Nov 15, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rangareddy District (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |