FDA Inspection
Milbar Laboratories, Inc.Milbar Laboratories, Inc. – FDA Inspection, May 17, 2016
Record Details
This FDA Inspection record concerns Milbar Laboratories, Inc., with an inspection on May 17, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Milbar Laboratories, Inc.
- Inspection Date
- May 17, 2016
- Product Type
- Drugs
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ID · 672d063e-b986-45da-a31c-526a590a28bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971848
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.58Buildings not maintained in good state of repair
- 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 211.192Investigations of discrepancies, failures
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.67(b)Written procedures not established/followed
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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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