MSN Laboratories PRIVATE LIMITED
Form 483 issued November 15, 2019 · NANDIGAMA, India
- Inspection
- Nov 4 – Nov 15, 2019
- Observations
- 5
- Pages
- 9
- FEI number
- 3011033544
In short: On November 15, 2019, FDA issued a Form 483 with 5 observations to MSN Laboratories PRIVATE LIMITED in NANDIGAMA, Telangana (FEI 3011033544) after an inspection that ran Nov 4 – Nov 15, 2019. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Production and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 04
Written procedures are not established and followed that describe the examinations to be conducted on appropriate…
This inspection in context
Questions about this 483
What did FDA find at MSN Laboratories PRIVATE LIMITED?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was MSN Laboratories PRIVATE LIMITED inspected by FDA?
The inspection ran Nov 4 – Nov 15, 2019, and the Form 483 is dated November 15, 2019.
How do I get the full Form 483 for MSN Laboratories PRIVATE LIMITED?
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.