MSN Laboratories Private Limited (Formulations Division, Unit-II) FDA Record
MSN Laboratories Private Limited (Formulations Division, Unit-II) has 1 FDA recall, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "MSN Laboratories Private Limited (Formulations Division, Unit-II)" is on file.
- Latest recall
- D-0113-2027 · Class II · Oct 21, 2026
- Latest inspection
- Dec 21, 2023 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 4 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 1 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0113-2027 | Class II | Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only, Manufactured by: MSL… | Oct 21, 2026 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 21, 2023 | Rangareddy District, India | Drugs | Voluntary Action Indicated (VAI) | 3011033544 |
| Nov 15, 2019 | Rangareddy District, India | Drugs | Voluntary Action Indicated (VAI) | 3011033544 |
| Feb 28, 2018 | Rangareddy District, India | Drugs | No Action Indicated (NAI) | 3011033544 |
| Jul 21, 2017 | Rangareddy District, India | Drugs | No Action Indicated (NAI) | 3011033544 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3011033544 | Rangareddy District, India | 4 | Dec 21, 2023 |
MSN Laboratories Private Limited (Formulations Division, Unit-II) and the FDA: common questions
Has MSN Laboratories Private Limited (Formulations Division, Unit-II) received an FDA warning letter?
No FDA warning letter addressed to the name "MSN Laboratories Private Limited (Formulations Division, Unit-II)" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has MSN Laboratories Private Limited (Formulations Division, Unit-II) received an FDA Form 483?
FDA has not published a Form 483 for "MSN Laboratories Private Limited (Formulations Division, Unit-II)" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect MSN Laboratories Private Limited (Formulations Division, Unit-II)?
The most recent FDA inspection on file ended Dec 21, 2023 at Rangareddy District, India and was classified VAI. FDA has 4 inspections of MSN Laboratories Private Limited (Formulations Division, Unit-II) on file.
Has MSN Laboratories Private Limited (Formulations Division, Unit-II) had an FDA recall?
Yes. MSN Laboratories Private Limited (Formulations Division, Unit-II) has 1 FDA recall on record. The most recent started Oct 21, 2026.
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