Mylan Laboratories Limited
Form 483 issued May 27, 2022 · Bangalore, India
- Inspection
- May 19 – May 27, 2022
- Investigators
- Anastasia M. Shields· Jose E. Melendez
- Observations
- 2
- Pages
- 4
- FEI number
- 3007512701
In short: On May 27, 2022, FDA issued a Form 483 with 2 observations to Mylan Laboratories Limited in Bangalore, Karnataka (FEI 3007512701) after an inspection that ran May 19 – May 27, 2022. The investigators were Anastasia M. Shields and Jose E. Melendez. 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×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
In-process samples are not representative. The sampling process for in-process samples and semi-finished products (i.e., OM)…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
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 211.160
See how FDA wrote the same problem up elsewhere.
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.
Who inspected Mylan Laboratories Limited?
Anastasia M. Shields and Jose E. Melendez are named on this Form 483, for the inspection of May 19 – May 27, 2022. Each investigator has a profile showing what they cite most.
When was Mylan Laboratories Limited inspected by FDA?
The inspection ran May 19 – May 27, 2022, and the Form 483 is dated May 27, 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.