Drug factory · FDA FEI 3015621300
Ocean Healthcare Pvt Ltd
86 /1-6 Orathur Village, Thiruporur Taluk, Chengalpattu, India
Problems found, fixed voluntarily at FDA's last inspection, Jun 14, 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
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 14, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 14, 2024 inspection
- Complaints reviewed by Quality Control Unit 21 CFR 211.198(a)
Written procedures describing the handling of complaints do not include provisions for explaining the reasons for the failure of the batch or any of its components to meet specifications. - 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. - Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: label; manufacture; pack.