Mylan Laboratories Limited — Hosur
USFDA inspection record for FEI 3008255419, Hosur, India.
VAI
Latest classification
2
Inspections on record
5
Form 483 observations on record
History (newest first)
Inspections
17 May 2024
VAI — Voluntary action indicated
Drug Quality Assurance · Drugs · FY2024
Source: FDA Data Dashboard ↗
17 Sep 2021
VAI — Voluntary action indicated
Drug Quality Assurance · Drugs · FY2021
Form 483: 5 observations
- Validation lacking for sterile drug products (21 CFR 211.113(b))
- Environmental Monitoring System (21 CFR 211.42(c)(10)(iv))
- Equipment to control conditions (21 CFR 211.42(c)(10)(vi))
- Training , Education , Experience overall (21 CFR 211.25(a))
- Equipment for Environmental Control (21 CFR 211.46(b))
Source: FDA Data Dashboard ↗
📎 Cite this data: Source: PharmaRoz, FDA inspection record for FEI 3008255419, updated 12 Nov 2026