Drug factory · FDA FEI 3004540907
OrBion Pharmaceuticals Private Limited
Plot No.B5 (Part) and B6 (Part), SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kancheepuram, India
No problems found at FDA's last inspection, Oct 27, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2011: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 27, 2025 | No problems found | Drug Quality Assurance | — |
| Sep 8, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| May 31, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Jun 3, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 14, 2013 | No problems found | Drug Quality Assurance | — |
| Apr 7, 2011 | 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 8, 2023 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established specifications, standards and laboratory control mechanisms are not followed. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use and cleaning and maintenance.
May 31, 2019 inspection
- Tablet or capsule weight variation 21 CFR 211.110(a)(1)
The in-process control procedures were deficient in that it did not include an examination of tablet and capsule weight variation. - Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity. - Test methods 21 CFR 211.165(e)
The accuracy and sensitivity of test methods have not been established. - 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.
Registered with FDA for: analysis; label; manufacture; pack.