FDA Inspection
Guardian Drug Co. Inc.Guardian Drug Co. Inc. – FDA Inspection, Feb 18, 2011
Record Details
This FDA Inspection record concerns Guardian Drug Co. Inc., with an inspection on February 18, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Guardian Drug Co. Inc.
- Inspection Date
- February 18, 2011
- Product Type
- Drugs
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ID · ac4db374-213a-4395-9b61-d26e0b8af99d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710017
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Guardian Drug Co. Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2026 | Not classified | New Jersey District Office | |
| November 7, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 17, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 6, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 6, 2016 | Not classified | New Jersey District Office |
Other documents for Guardian Drug Co. Inc.
- FDA Inspection 1304382 - 2026-01-16
- FDA Inspection 1231141 - 2024-11-07
- FDA Inspection 1162476 - 2022-02-17
- FDA Inspection 1030766 - 2017-11-06
- FDA Inspection 996009 - 2016-12-06
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