FDA Inspection
Manuel Enterprises, Inc. dba Nepenthe Home Medical EquipmentManuel Enterprises, Inc. dba Nepenthe Home Medical Equipment – FDA Inspection, Apr 29, 2011
Record Details
This FDA Inspection record concerns Manuel Enterprises, Inc. dba Nepenthe Home Medical Equipment, with an inspection on April 29, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 29, 2011
- Product Type
- Drugs
View Company Profile
ID · cd947b0f-8ee2-408c-ab55-deddfe9b4bff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 723741
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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