FDA Inspection
Two Old GoatsTwo Old Goats – FDA Inspection, Oct 16, 2014
Record Details
This FDA Inspection record concerns Two Old Goats, with an inspection on October 16, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Two Old Goats
- Inspection Date
- October 16, 2014
- Product Type
- Drugs
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ID · 8f37ceba-995a-4218-bc30-32bee530c23f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 900501
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
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