FDA Inspection
Johnson Creek Enterprises, LLCJohnson Creek Enterprises, LLC – FDA Inspection, Sep 25, 2009
Record Details
This FDA Inspection record concerns Johnson Creek Enterprises, LLC, with an inspection on September 25, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 25, 2009
- Product Type
- Drugs
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ID · 4d562ce4-3776-4582-81dc-8141f6b79cff
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 614153
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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