FDA Inspection
Ortho Biologics, LLCOrtho Biologics, LLC – FDA Inspection, Jun 28, 2010
Record Details
This FDA Inspection record concerns Ortho Biologics, LLC, with an inspection on June 28, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ortho Biologics, LLC
- Inspection Date
- June 28, 2010
- Product Type
- Drugs
View Company Profile
ID · 09a3b50e-c815-41d1-8f16-9cb41ddb538e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 669409
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Ortho Biologics, LLC
14| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 25, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 20, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 12, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 11, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ortho Biologics, LLC
- FDA Inspection 1118152 - 2020-01-24
- FDA Inspection 1089445 - 2019-04-25
- FDA Inspection 1022029 - 2017-07-20
- FDA Inspection 1015645 - 2017-05-12
- FDA Inspection 963080 - 2016-02-11
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