FDA Inspection
Pace Analytical Life Sciences, LLCFDA Inspection 1042666 - Pace Analytical Life Sciences, LLC - February 07, 2018
Record Details
This FDA Inspection record concerns Pace Analytical Life Sciences, LLC, with an inspection on February 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 7, 2018
- Product Type
- Drugs
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ID · 181d46ef-3006-4010-8c64-cfb48e957793
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042666
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Pace Analytical Life Sciences, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 4, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 8, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pace Analytical Life Sciences, LLC
- FDA Inspection 1245318 - 2024-07-19
- FDA Inspection 925785 - 2015-05-04
- FDA Inspection 826239 - 2013-04-08
- FDA Inspection 708788 - 2011-02-07
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