FDA Inspection
Swabplus, L.P.Swabplus, L.P. – FDA Inspection, Aug 1, 2023
Record Details
This FDA Inspection record concerns Swabplus, L.P., with an inspection on August 1, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b628edca-ddf8-4ecf-9564-7de5a714ce0d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1211441
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
20- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Swabplus, L.P.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 15, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 30, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 28, 2014 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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