FDA Inspection
Wayne Chemical Inc.Wayne Chemical Inc. – FDA Inspection, Apr 30, 2010
Record Details
This FDA Inspection record concerns Wayne Chemical Inc., with an inspection on April 30, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Wayne Chemical Inc.
- Inspection Date
- April 30, 2010
- Product Type
- Drugs
View Company Profile
ID · a0b6d469-801e-4b6b-a027-c72720c59d57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661196
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.184(c)Individual inventory record
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Wayne Chemical Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Wayne Chemical Inc.
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.