FDA Inspection
Milbar Laboratories, Inc.Milbar Laboratories, Inc. – FDA Inspection, Dec 27, 2017
Record Details
This FDA Inspection record concerns Milbar Laboratories, Inc., with an inspection on December 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 42b763bc-97ea-4388-8b6d-0670d125bdd7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1036724
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Lack of quality control unit
- 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 |
| May 17, 2016 | VAI | 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 971848 - 2016-05-17
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