Drug factory · FDA FEI 3007648351
Mylan Laboratories Limited
Specialty Formulation Facility, Plot No: 284B/1, 289-292 Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bengaluru, India
No problems found at FDA's last inspection, Feb 24, 2023.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2013: 1 with no problems, 5 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Mycophenolic Acid | Makes it, tests it, packages it, labels it and sterilizes it | Mylan Institutional LLC | 67457-386 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 24, 2023 | No problems found | Drug Quality Assurance | — |
| Feb 28, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 13, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 12 |
| Mar 2, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 18, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 13, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 3, 2014 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jun 27, 2013 | Serious problems, FDA action | 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.
May 13, 2019 inspection
- Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not justified. - SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. - Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size and location to facilitate cleaning, maintenance, and proper operations. - Control / Lab Operations Area 21 CFR 211.42(c)(9)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations. - Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over air pressure, humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. - Air recirculation of dust from production areas 21 CFR 211.46(c)
Air is recirculated to production areas, without adequate measures to control recirculation of dust. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located to facilitate operations for its intended use. - Equipment construction - reactive surfaces 21 CFR 211.65(a)
Equipment surfaces that contact drug products are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Backup data not assured as exact and complete 21 CFR 211.68(b)
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.