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FDA Inspection
•Milbar Laboratories, Inc.•January 27, 2010

Milbar Laboratories, Inc. – FDA Inspection, Jan 27, 2010

Record Details

This FDA Inspection record concerns Milbar Laboratories, Inc., with an inspection on January 27, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Milbar Laboratories, Inc.
Inspection Date
January 27, 2010
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · b7abacc5-b2fe-4d5e-a967-3a119cacf0fd

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
642682
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

7
  1. 21 CFR 211.103Actual vs. theoretical yields not determined
  2. 21 CFR 211.101(d)Component addition checked by 2nd person
  3. 21 CFR 211.125(f)Procedures Written and Followed
  4. 21 CFR 211.84(d)(2)Reports of Analysis (Components)
  5. 21 CFR 211.100(a)Absence of Written Procedures
  6. 21 CFR 211.22(d)Procedures not in writing, fully followed
  7. 21 CFR 211.180(e)(1)Review of representative number of batches

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Milbar Laboratories, Inc.

7
DateClassificationOfficeProject area
November 7, 2024VAINew England District OfficeDrug Quality Assurance
January 2, 2024NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
September 27, 2022OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 11, 2019OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
December 27, 2017OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
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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