FDA Inspection
Mayon's Pharmaceuticals Private LtdMayon's Pharmaceuticals Private Ltd – FDA Inspection, Feb 20, 2020
Record Details
This FDA Inspection record concerns Mayon's Pharmaceuticals Private Ltd, with an inspection on February 20, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 20, 2020
- Product Type
- Drugs
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ID · 7316e5fb-c04d-44f3-8779-a865171da310
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1118299
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
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