MSN Laboratories Private Limited Unit-05, Sy. Nos. (Parts of)7,8,13 and
Form 483 issued December 11, 2025 · Farooqnagar Mandal, India
- Inspection
- Dec 5 – Dec 11, 2025
- Investigators
- Brandy N. Lepage· Jessica S. Estriplet
- Observations
- 5
- Pages
- 7
- FEI number
- 3035592613
In short: On December 11, 2025, FDA issued a Form 483 with 5 observations to MSN Laboratories Private Limited Unit-05, Sy. Nos. (Parts of)7,8,13 and in Farooqnagar Mandal, India (FEI 3035592613) after an inspection that ran Dec 5 – Dec 11, 2025. The investigators were Brandy N. Lepage and Jessica S. Estriplet. Most observations concern materials and quality system.
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Specific identification tests are not conducted on components that have been accepted based on the…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
In-process materials are not tested for quality and approved or rejected by the quality control unit…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmMSN Laboratories Private Limited Unit-05, Sy. Nos. (Parts of)7,8,13 and history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MSN Laboratories Private Limited Unit-05, Sy. Nos. (Parts of)7,8,13 and?
FDA listed 5 observations on this Form 483, mostly about materials, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected MSN Laboratories Private Limited Unit-05, Sy. Nos. (Parts of)7,8,13 and?
Brandy N. Lepage and Jessica S. Estriplet are named on this Form 483, for the inspection of Dec 5 – Dec 11, 2025. Each investigator has a profile showing what they cite most.
When was MSN Laboratories Private Limited Unit-05, Sy. Nos. (Parts of)7,8,13 and inspected by FDA?
The inspection ran Dec 5 – Dec 11, 2025, and the Form 483 is dated December 11, 2025.
How do I get the full Form 483 for MSN Laboratories Private Limited Unit-05, Sy. Nos. (Parts of)7,8,13 and?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.