FDA Inspection
Fragrance Manufacturing, Inc. dbs FMIFragrance Manufacturing, Inc. dbs FMI – FDA Inspection, Sep 21, 2009
Record Details
This FDA Inspection record concerns Fragrance Manufacturing, Inc. dbs FMI, with an inspection on September 21, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 21, 2009
- Product Type
- Drugs
View Company Profile
ID · e87a75e9-56b1-4032-8f9a-53c1f3391c2c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 613765
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 111.12(c)Personnel - education, training, experience
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 111.75(a)(2)Appropriate tests, examinations; certificate of analysis
- 21 CFR 111.15(b)(2)Physical plant - repair
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fragrance Manufacturing, Inc. dbs FMI
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2026 | Not classified | Philadelphia District Office | Drug Quality Assurance |
| September 14, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 22, 2019 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| August 25, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 2, 2014 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Fragrance Manufacturing, Inc. dbs FMI
- FDA Inspection 1314162 - 2026-04-24
- FDA Inspection 1179473 - 2022-09-14
- FDA Inspection 1106435 - 2019-08-22
- FDA Inspection 984569 - 2016-08-25
- FDA Inspection 871069 - 2014-04-02
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.