FDA Inspection
Custom RX LLC, dba Custom RX Compounding PharmacyCustom RX LLC, dba Custom RX Compounding Pharmacy – FDA Inspection, Aug 28, 2014
Record Details
This FDA Inspection record concerns Custom RX LLC, dba Custom RX Compounding Pharmacy, with an inspection on August 28, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 28, 2014
- Product Type
- Drugs
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ID · c1a5f236-39ec-44f2-98fc-c1d84db18d16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891798
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.110(a)Written in-process control procedures
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