FDA Inspection
Alimera Sciences IncAlimera Sciences Inc – FDA Inspection, Dec 20, 2016
Record Details
This FDA Inspection record concerns Alimera Sciences Inc, with an inspection on December 20, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 75eccf73-546e-4e81-91e6-647068c05e3c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004201
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
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Other FDA inspections of Alimera Sciences Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 9, 2019 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
Other documents for Alimera Sciences Inc
- FDA Inspection 1235296 - 2024-03-21
- FDA Inspection 1101451 - 2019-09-09
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