FDA Inspection
Navinta, LLCNavinta, LLC – FDA Inspection, Jun 29, 2023
Record Details
This FDA Inspection record concerns Navinta, LLC, with an inspection on June 29, 2023, issued by the New Jersey District Office.
- Company
- Navinta, LLC
- Inspection Date
- June 29, 2023
View Company Profile
ID · a32b14ce-5c4a-4a08-acb7-8ebf80958519
Inspection Facts
- Inspection number
- 1209856
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Navinta, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2024 | Not classified | New Jersey District Office | |
| May 4, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 28, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 18, 2018 | Not classified | New Jersey District Office | |
| August 18, 2017 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
Other documents for Navinta, LLC
- FDA Inspection 1252822 - 2024-09-30
- FDA Inspection 1205480 - 2023-05-04
- FDA Inspection 1084188 - 2019-03-28
- FDA Inspection 1070302 - 2018-09-18
- FDA Inspection 1022105 - 2017-08-18
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