FDA Inspection
InvaTech Pharma Solutions, LLCInvaTech Pharma Solutions, LLC – FDA Inspection, Jun 9, 2023
Record Details
This FDA Inspection record concerns InvaTech Pharma Solutions, LLC, with an inspection on June 9, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2d086648-ee7e-457c-a735-8d26296a25e8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1209653
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.122(d)Label storage access limited to authorized personnel
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Other FDA inspections of InvaTech Pharma Solutions, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2026 | Not classified | New Jersey District Office | Drug Quality Assurance |
| February 7, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 28, 2017 | VAI | New Jersey District Office | Generic Drug Evaluation |
| April 4, 2017 | Not classified | New Jersey District Office | |
| November 8, 2016 | Not classified | New Jersey District Office |
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