Mylan Laboratories Limited
Form 483 issued January 16, 2023 · Bengaluru, India
- Observations
- 2
- Pages
- 2
- FEI number
- 3007648351
In short: On January 16, 2023, FDA issued a Form 483 with 2 observations to Mylan Laboratories Limited in Bengaluru, Karnataka (FEI 3007648351). Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Mylan Laboratories Limited?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Mylan Laboratories Limited inspected by FDA?
This Form 483 is dated January 16, 2023.
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.