FDA Inspection
Apace Packaging LLCApace Packaging LLC – FDA Inspection, Sep 23, 2011
Record Details
This FDA Inspection record concerns Apace Packaging LLC, with an inspection on September 23, 2011, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Apace Packaging LLC
- Inspection Date
- September 23, 2011
- Product Type
- Veterinary
View Company Profile
ID · 682b71ec-8d50-4d4f-9891-b8a2578b9141
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 743880
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
16- 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.198(a)Quality Control Review
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.125(b)Examination of issued labels
- 21 CFR 211.122(b)Rejection of unapproved labeling/packaging materials
- 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.125(f)Procedures Written and Followed
Showing 10 of 16 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Apace Packaging LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 17, 2019 | Not classified | Cincinnati District Office | |
| August 4, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 30, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 24, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apace Packaging LLC
- FDA Inspection 1161276 - 2022-01-13
- FDA Inspection 1081431 - 2019-01-17
- FDA Inspection 983050 - 2016-08-04
- FDA Inspection 844093 - 2013-07-30
- FDA Inspection 796038 - 2012-08-24
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.