FDA Inspection
MSN Laboratories Private Limited (Formulations Division, Unit-II)MSN Laboratories Private Limited (Formulations Division, Unit-II) – FDA Inspection, Dec 21, 2023
Record Details
This FDA Inspection record concerns MSN Laboratories Private Limited (Formulations Division, Unit-II), with an inspection on December 21, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 21, 2023
- Product Type
- Drugs
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ID · 24d04f51-d61f-4c12-be9b-e3642faac013
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1226168
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(b)In-process conformity - examination, sample testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of MSN Laboratories Private Limited (Formulations Division, Unit-II)
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2019 | Not classified | Office of Inspections and Investigations | |
| February 28, 2018 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| July 21, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2017 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
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