FDA Inspection
FDC LimitedFDC Limited – FDA Inspection, Aug 16, 2018
Record Details
This FDA Inspection record concerns FDC Limited, with an inspection on August 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 3205da5c-8721-40b4-b4b9-1cd628ab893f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062631
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of FDC Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 1, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 6, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for FDC Limited
- FDA Inspection 1202011 - 2023-02-12
- FDA Inspection 979497 - 2016-07-01
- FDA Inspection 880907 - 2014-05-06
- FDA Inspection 776677 - 2012-02-21
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.