FDA Inspection
Pharmaron Lab Services, LLCPharmaron Lab Services, LLC – FDA Inspection, Jun 14, 2011
Record Details
This FDA Inspection record concerns Pharmaron Lab Services, LLC, with an inspection on June 14, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pharmaron Lab Services, LLC
- Inspection Date
- June 14, 2011
- Product Type
- Drugs
View Company Profile
ID · 0857d82a-dbc8-455f-841f-909c5fc4c49f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 729624
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Pharmaron Lab Services, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 17, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 13, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pharmaron Lab Services, LLC
- FDA Inspection 917345 - 2015-03-13
- FDA Inspection 816003 - 2013-01-17
- FDA Inspection 639035 - 2010-01-13
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