FDA Inspection
MSN Laboratories Private Limited (Formulations Division, Unit-II)MSN Laboratories Private Limited (Formulations Division, Unit-II) – FDA Inspection, Feb 3, 2017
Record Details
This FDA Inspection record concerns MSN Laboratories Private Limited (Formulations Division, Unit-II), with an inspection on February 3, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- February 3, 2017
- Product Type
- Human Drugs
- People
- Anastasia M. Shields (FDA Associated Person)
- Kumar G. Janoria (Issuing Officer)
- Linda F. Murphy (FDA Associated Person)
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ID · f7e2cbb5-ed95-451d-9f23-c7badb025238
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002592
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.25(a)Training , Education , Experience overall
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Other FDA inspections of MSN Laboratories Private Limited (Formulations Division, Unit-II)
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
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