FDA Inspection
Twincraft Inc.Twincraft Inc. – FDA Inspection, Aug 25, 2020
Record Details
This FDA Inspection record concerns Twincraft Inc., with an inspection on August 25, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Twincraft Inc.
- Inspection Date
- August 25, 2020
- Product Type
- Drugs
View Company Profile
ID · f9526a60-aba1-4017-b9b7-36cb8888dc80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1127641
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.194(a)(7)Identification of Person Performing the Testing
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.101(a)Batches Formulated to less than 100%
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Twincraft Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 6, 2025 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| August 3, 2017 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| June 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 18, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Twincraft Inc.
- FDA Inspection 1268216 - 2025-04-22
- FDA Inspection 1262849 - 2025-02-06
- FDA Inspection 1023785 - 2017-08-03
- FDA Inspection 937989 - 2015-06-25
- FDA Inspection 793576 - 2012-07-18
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