FDA Inspection
TX OptionsTX Options – FDA Inspection, Nov 29, 2016
Record Details
This FDA Inspection record concerns TX Options, with an inspection on November 29, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · aada350a-0860-4348-9aed-05f3e7156534
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993337
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of TX Options
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2008 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for TX Options
- FDA Inspection 546476 - 2008-11-05
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