FDA Inspection
Recipharm HC LimitedRecipharm HC Limited – FDA Inspection, Jun 27, 2023
Record Details
This FDA Inspection record concerns Recipharm HC Limited, with an inspection on June 27, 2023, issued by the Office of Inspections and Investigations.
- Company
- Recipharm HC Limited
- Inspection Date
- June 27, 2023
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ID · 1343c37e-f8a4-43b9-a739-3fd2c02c0761
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1209510
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(b)Representative Samples
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Other FDA inspections of Recipharm HC Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 26, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 15, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 7, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 9, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Recipharm HC Limited
- FDA Inspection 1156170 - 2020-11-26
- FDA Inspection 1065951 - 2017-11-10
- FDA Inspection 956577 - 2016-01-15
- FDA Inspection 869740 - 2014-03-07
- FDA Inspection 748166 - 2011-09-09
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