FDA Inspection
Apotheca, Inc.Apotheca, Inc. – FDA Inspection, Jan 29, 2009
Record Details
This FDA Inspection record concerns Apotheca, Inc., with an inspection on January 29, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Apotheca, Inc.
- Inspection Date
- January 29, 2009
- Product Type
- Drugs
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ID · e3bc9fe2-39ff-4251-96b4-942b2d0da052
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 561460
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.42(d)Penicillin processing area not kept separate
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Apotheca, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 11, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 3, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apotheca, Inc.
- FDA Inspection 1259320 - 2025-01-08
- FDA Inspection 1028450 - 2017-10-11
- FDA Inspection 951427 - 2015-10-22
- FDA Inspection 749026 - 2011-10-03
- FDA Inspection 677384 - 2010-08-23
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