FDA Inspection
Gamma Agro-Medical Processings Pvt LtdGamma Agro-Medical Processings Pvt Ltd – FDA Inspection, Oct 30, 2019
Record Details
This FDA Inspection record concerns Gamma Agro-Medical Processings Pvt Ltd, with an inspection on October 30, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 30, 2019
- Product Type
- Drugs
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ID · d8a20bed-5219-421e-aed5-aad4ac87da76
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1110582
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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