FDA Inspection
Frenda CorporationFrenda Corporation – FDA Inspection, Aug 1, 2022
Record Details
This FDA Inspection record concerns Frenda Corporation, with an inspection on August 1, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Frenda Corporation
- Inspection Date
- August 1, 2022
- Product Type
- Drugs
View Company Profile
ID · e305a2f0-6707-4a84-9459-6d4b814ee9b1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1175963
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 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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