FDA Inspection
Greenline LaboratoriesGreenline Laboratories – FDA Inspection, Apr 8, 2010
Record Details
This FDA Inspection record concerns Greenline Laboratories, with an inspection on April 8, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Greenline Laboratories
- Inspection Date
- April 8, 2010
- Product Type
- Drugs
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ID · fdde3599-75ac-4612-9fed-cf09fedddbd6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653222
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)(3)Retention time for exempt OTC drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.22(a)Lack of quality control unit
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