FDA Inspection
Apotheca Supply, IncApotheca Supply, Inc – FDA Inspection, Jan 6, 2010
Record Details
This FDA Inspection record concerns Apotheca Supply, Inc, with an inspection on January 6, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Apotheca Supply, Inc
- Inspection Date
- January 6, 2010
- Product Type
- Drugs
View Company Profile
ID · 6dd85310-312d-4bf3-8fd6-5823cbb2734a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 638122
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.67(b)(4)Cleaning SOPs/equipment identification
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Apotheca Supply, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 4, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apotheca Supply, Inc
- FDA Inspection 914185 - 2015-02-12
- FDA Inspection 588854 - 2009-06-04
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