FDA Inspection
C. O. Truxton Inc.C. O. Truxton Inc. – FDA Inspection, Jun 1, 2017
Record Details
This FDA Inspection record concerns C. O. Truxton Inc., with an inspection on June 1, 2017, issued by the New Jersey District Office, covering human drugs.
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ID · c53e33f7-8e3c-4056-8ad8-8c0f53e89220
Inspection Facts
- Inspection number
- 1012380
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.44Adequate lighting not provided
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Other FDA inspections of C. O. Truxton Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for C. O. Truxton Inc.
- FDA Inspection 1045311 - 2018-03-19
- FDA Inspection 944331 - 2015-09-21
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