FDA Inspection
Milbar Laboratories, Inc.Milbar Laboratories, Inc. – FDA Inspection, Apr 2, 2013
Record Details
This FDA Inspection record concerns Milbar Laboratories, Inc., with an inspection on April 2, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Milbar Laboratories, Inc.
- Inspection Date
- April 2, 2013
- Product Type
- Drugs
View Company Profile
ID · b8d60d01-9010-479f-9185-317ba40d33f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823829
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Milbar Laboratories, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2024 | VAI | New England District Office | Drug Quality Assurance |
| January 2, 2024 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| September 27, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 11, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 27, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Milbar Laboratories, Inc.
- FDA Inspection 1253807 - 2024-11-07
- FDA Inspection 1231023 - 2024-01-02
- FDA Inspection 1180954 - 2022-09-27
- FDA Inspection 1107471 - 2019-10-11
- FDA Inspection 1036724 - 2017-12-27
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