FDA Inspection
PureTek CorporationPureTek Corporation – FDA Inspection, Jul 16, 2010
Record Details
This FDA Inspection record concerns PureTek Corporation, with an inspection on July 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- PureTek Corporation
- Inspection Date
- July 16, 2010
- Product Type
- Drugs
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ID · b9cffb91-8b6c-4880-860e-ed3928a7ca80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 675510
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.198(a)Adverse Drug Experience
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.198(b)Records maintained for 1 year (except certain OTC drugs)
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Other FDA inspections of PureTek Corporation
9| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2025 | VAI | Los Angeles District Office | Drug Quality Assurance |
| January 30, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 27, 2015 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| March 18, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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