FDA Inspection
J. B. Chemicals and Pharmaceuticals LimitedJ. B. Chemicals and Pharmaceuticals Limited – FDA Inspection, Aug 24, 2018
Record Details
This FDA Inspection record concerns J. B. Chemicals and Pharmaceuticals Limited, with an inspection on August 24, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Nije A. Thomas (Company Rep)
- Rachael L. Derby (Issuing Officer)
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ID · 380fa294-9d75-467b-a1ee-506b2306d920
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064488
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of J. B. Chemicals and Pharmaceuticals Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 18, 2018 | Not classified | Office of Inspections and Investigations | |
| June 24, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for J. B. Chemicals and Pharmaceuticals Limited
- FDA Inspection 1233390 - 2022-10-23
- FDA Inspection 1117757 - 2020-02-07
- FDA Inspection 1073375 - 2018-10-18
- FDA Inspection 978487 - 2016-06-24
- FDA Inspection 852629 - 2013-10-18
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