FDA Inspection
NGL NE LLP, dba Shoreline Compressed GasNGL NE LLP, dba Shoreline Compressed Gas – FDA Inspection, Jan 9, 2013
Record Details
This FDA Inspection record concerns NGL NE LLP, dba Shoreline Compressed Gas, with an inspection on January 9, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 9, 2013
- Product Type
- Drugs
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ID · 8e11958d-82c8-4b60-a66c-8f456c161256
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 813393
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.198(a)Reporting of adverse drug experience to FDA
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