Drug factory · FDA FEI 3008255419
Mylan Laboratories Limited
Hosur Steriles Facility, Plot No. 13A, 14, & CP 2, Sipcot Phase II, Krishnagiri Main Road, Hosur, India
Problems found, fixed voluntarily at FDA's last inspection, May 17, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2010: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Adenosine | Makes it, tests it, packages it, labels it and sterilizes it | Mylan Institutional LLC | 67457-856, 67457-857, 72078-033 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 17, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 17, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Sep 13, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 10, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 17, 2021 inspection
- Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture of a drug product lack the education, training and experience required to perform their assigned functions. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Equipment to control conditions 21 CFR 211.42(c)(10)(vi)
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. - Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over air pressure, micro-organisms, humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.