FDA Inspection
MSN Laboratories Private Limited (Formulations Division, Unit-II)MSN Laboratories Private Limited (Formulations Division, Unit-II) – FDA Inspection, Feb 28, 2018
Record Details
This FDA Inspection record concerns MSN Laboratories Private Limited (Formulations Division, Unit-II), with an inspection on February 28, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 28, 2018
- Product Type
- Drugs
View Company Profile
ID · 3702691e-185c-482e-b4b5-4673f5f2dbf4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042443
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 211.84(c)(2)Containers sampled so as to prevent contamination
Full citation text and observation details available on the Dashboard.
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 | |
| 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 |
Other documents for MSN Laboratories Private Limited (Formulations Division, Unit-II)
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.