FDA Inspection
Pennsylvania Correctional IndustriesPennsylvania Correctional Industries – FDA Inspection, Mar 21, 2012
Record Details
This FDA Inspection record concerns Pennsylvania Correctional Industries, with an inspection on March 21, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 21, 2012
- Product Type
- Drugs
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ID · 2702335f-d0bc-4eee-99c3-aba426868cf8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 773305
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
28- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(a)Quality Control Review
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.142Written warehousing procedures established/followed
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