FDA Inspection
Pharmacia Hepar, LLCPharmacia Hepar, LLC – FDA Inspection, May 25, 2010
Record Details
This FDA Inspection record concerns Pharmacia Hepar, LLC, with an inspection on May 25, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pharmacia Hepar, LLC
- Inspection Date
- May 25, 2010
- Product Type
- Drugs
View Company Profile
ID · 4f85a358-82c8-443c-9d87-91d9cbe149d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 663045
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Pharmacia Hepar, LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 23, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 20, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 17, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pharmacia Hepar, LLC
- FDA Inspection 1238137 - 2024-05-01
- FDA Inspection 1002902 - 2017-02-23
- FDA Inspection 985351 - 2016-09-20
- FDA Inspection 891787 - 2014-08-20
- FDA Inspection 836286 - 2013-06-17
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