FDA Inspection
Indoco Remedies Limited (Plant I)Indoco Remedies Limited (Plant I) – FDA Inspection, Jan 19, 2018
Record Details
This FDA Inspection record concerns Indoco Remedies Limited (Plant I), with an inspection on January 19, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 260548d0-db26-4dcd-99d6-aff8af603558
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1039323
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.184(d)Labeling: documentation of exam and review
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(1)Sample size - test intervals
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Indoco Remedies Limited (Plant I)
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2023 | VAI | Office of Inspections and Investigations | |
| January 20, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 25, 2019 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| October 29, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Indoco Remedies Limited (Plant I)
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.