FDA Inspection
Foshan Aqua Gel Biotech Co., Ltd.Foshan Aqua Gel Biotech Co., Ltd. – FDA Inspection, Dec 4, 2015
Record Details
This FDA Inspection record concerns Foshan Aqua Gel Biotech Co., Ltd., with an inspection on December 4, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 4, 2015
- Product Type
- Drugs
View Company Profile
ID · 1cc8c0ed-1174-48a4-9d60-4828a4ab55b4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 956318
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.182Personnel dating/signing equipment log
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.166(a)(4)Testing in same container - closure system
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Other FDA inspections of Foshan Aqua Gel Biotech Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2024 | Not classified | Office of Inspections and Investigations | |
| September 12, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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