FDA Inspection
TELL Enterprises IncTELL Enterprises Inc – FDA Inspection, Aug 10, 2015
Record Details
This FDA Inspection record concerns TELL Enterprises Inc, with an inspection on August 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- TELL Enterprises Inc
- Inspection Date
- August 10, 2015
- Product Type
- Drugs
View Company Profile
ID · 4482821d-fcc4-4b9e-9f7f-642b2f533a09
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 940953
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.80(a)Procedures To Be in Writing
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