FDA Inspection
MW Encap Ltd.(NextPharma Edinburgh)MW Encap Ltd.(NextPharma Edinburgh) – FDA Inspection, Dec 14, 2018
Record Details
This FDA Inspection record concerns MW Encap Ltd.(NextPharma Edinburgh), with an inspection on December 14, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · e9f1d332-e520-4808-96b2-ae97790a06a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075149
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 212.20(d)Determination need for investigation
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Other FDA inspections of MW Encap Ltd.(NextPharma Edinburgh)
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| June 24, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 20, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for MW Encap Ltd.(NextPharma Edinburgh)
- FDA Inspection 1336234 - 2026-09-18
- FDA Inspection 1210120 - 2021-06-24
- FDA Inspection 1155582 - 2018-02-09
- FDA Inspection 957007 - 2016-01-22
- FDA Inspection 909628 - 2014-11-20
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