FDA Inspection
Laboratorios Columbia, S.A. de C.V.Laboratorios Columbia, S.A. de C.V. – FDA Inspection, Jul 22, 2016
Record Details
This FDA Inspection record concerns Laboratorios Columbia, S.A. de C.V., with an inspection on July 22, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 22, 2016
- Product Type
- Drugs
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ID · 8dd0fdf0-381f-4065-b764-13e330c4762b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995561
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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