Drug factory · FDA FEI 3018899465
Brooks Steriscience Limited
Block No. Survey No. 61/62, Manglej village, Nareshwar Road, Karjan Taluka, , Vadodara, India
Problems found, fixed voluntarily at FDA's last inspection, Nov 12, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Meropenem | Makes it, tests it, packages it and labels it | Armas Pharmaceuticals Inc., Brooks Steriscience Limited, Civica, Inc., Mylan Institutional LLC | 72485-411, 72485-412, 81962-000 +5 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 12, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 12, 2024 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate 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. - 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. - 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. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.