FDA Inspection
Oaklock, LlcOaklock, Llc – FDA Inspection, Aug 25, 2015
Record Details
This FDA Inspection record concerns Oaklock, Llc, with an inspection on August 25, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Oaklock, Llc
- Inspection Date
- August 25, 2015
- Product Type
- Drugs
View Company Profile
ID · ea3c736d-6287-48a3-bb57-75bad4bd9f79
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 940148
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 310.305(c)Failure to submit ADE report
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.204Returned drug products identified and held
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
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