FDA Inspection
Milbar Laboratories, Inc.Milbar Laboratories, Inc. – FDA Inspection, Nov 7, 2024
Record Details
This FDA Inspection record concerns Milbar Laboratories, Inc., with an inspection on November 7, 2024, issued by the New England District Office, covering human drugs.
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ID · 39e24588-bd00-4fd0-a7d9-b6b063552ab4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1253807
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Milbar Laboratories, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| May 17, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Milbar Laboratories, Inc.
- FDA Inspection 1231023 - 2024-01-02
- FDA Inspection 1180954 - 2022-09-27
- FDA Inspection 1107471 - 2019-10-11
- FDA Inspection 1036724 - 2017-12-27
- FDA Inspection 971848 - 2016-05-17
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