Mylan Laboratories Limited
Form 483 issued May 17, 2024 · Hosur, India
- Inspection
- May 6 – May 17, 2024
- Investigators
- Kevin P. Regan· Patty P. Kaewussdangkul
- Observations
- 5
- Pages
- 7
- FEI number
- 3008255419
In short: On May 17, 2024, FDA issued a Form 483 with 5 observations to Mylan Laboratories Limited in Hosur, Tamil Nadu (FEI 3008255419) after an inspection that ran May 6 – May 17, 2024. The investigators were Kevin P. Regan and Patty P. Kaewussdangkul. Most observations concern facilities & equipment and production.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Written records are not made of…
- 04
Field Alert Report was not submitted within three working days of receipt of information concerning a…
This inspection in context
Kevin P. Regan
7 documents · 2021–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Minnesota.
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
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 opening words of each observation are shown on this page.
Who inspected Mylan Laboratories Limited?
Kevin P. Regan and Patty P. Kaewussdangkul are named on this Form 483, for the inspection of May 6 – May 17, 2024. Each investigator has a profile showing what they cite most.
When was Mylan Laboratories Limited inspected by FDA?
The inspection ran May 6 – May 17, 2024, and the Form 483 is dated May 17, 2024.
How do I get the full Form 483 for Mylan Laboratories 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.