FDA Inspection
Weeks & Leo Co IncWeeks & Leo Co Inc – FDA Inspection, Sep 14, 2009
Record Details
This FDA Inspection record concerns Weeks & Leo Co Inc, with an inspection on September 14, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Weeks & Leo Co Inc
- Inspection Date
- September 14, 2009
- Product Type
- Drugs
View Company Profile
ID · f3645def-6603-4d3c-a386-a048de35521a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 610893
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.170(b)Investigation of reserve sample deterioration
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.103Yield calculations not verified by 2nd person
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Weeks & Leo Co Inc
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2021 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| March 29, 2018 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| April 10, 2015 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 20, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Weeks & Leo Co Inc
- FDA Inspection 1168338 - 2022-04-07
- FDA Inspection 1153842 - 2021-09-20
- FDA Inspection 1046209 - 2018-03-29
- FDA Inspection 921147 - 2015-04-10
- FDA Inspection 821676 - 2013-02-20
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.