Mylan Laboratories Limited
Form 483 issued September 23, 2022 · Hosur, India
- Inspection
- Sep 15 – Sep 23, 2022
- Investigator
- Thomas J. Arista
- Observations
- 6
- Pages
- 8
- FEI number
- 3008255419
In short: On September 23, 2022, FDA issued a Form 483 with 6 observations to Mylan Laboratories Limited in Hosur, Tamil Nadu (FEI 3008255419) after an inspection that ran Sep 15 – Sep 23, 2022. The investigator was Thomas J. Arista. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine inspection and checking of automatic and electronic equipment is not performed according to a written…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Thomas J. Arista
21 documents · 2001–2022
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mylan Laboratories Limited?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Mylan Laboratories Limited?
Thomas J. Arista is named on this Form 483, for the inspection of Sep 15 – Sep 23, 2022. Each investigator has a profile showing what they cite most.
When was Mylan Laboratories Limited inspected by FDA?
The inspection ran Sep 15 – Sep 23, 2022, and the Form 483 is dated September 23, 2022.
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.