Mylan Laboratories Limited
Form 483 issued September 17, 2021 · Hosur, India
- Inspection
- Sep 6 – Sep 17, 2021
- Investigator
- Rita K. Kabaso
- Observations
- 5
- Pages
- 7
- FEI number
- 3008255419
In short: On September 17, 2021, FDA issued a Form 483 with 5 observations to Mylan Laboratories Limited in Hosur, Tamil Nadu (FEI 3008255419) after an inspection that ran Sep 6 – Sep 17, 2021. The investigator was Rita K. Kabaso. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Employees engaged in the manufacture of a drug product lack the education, training and experience required…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
This inspection in context
Rita K. Kabaso
18 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMylan Laboratories Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mylan Laboratories Limited?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Mylan Laboratories Limited?
Rita K. Kabaso is named on this Form 483, for the inspection of Sep 6 – Sep 17, 2021. Each investigator has a profile showing what they cite most.
When was Mylan Laboratories Limited inspected by FDA?
The inspection ran Sep 6 – Sep 17, 2021, and the Form 483 is dated September 17, 2021.
How do I get the full Form 483 for Mylan Laboratories Limited?
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