FDA Inspection
King Pharmaceuticals LLCKing Pharmaceuticals LLC – FDA Inspection, Mar 16, 2011
Record Details
This FDA Inspection record concerns King Pharmaceuticals LLC, with an inspection on March 16, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- King Pharmaceuticals LLC
- Inspection Date
- March 16, 2011
- Product Type
- Drugs
View Company Profile
ID · 6a50e321-51c5-4502-b50c-9f41d1bdca03
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 713757
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.84(d)(3)Testing Containers & Closures Conformity with Specs
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of King Pharmaceuticals LLC
10| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2025 | OAI | Detroit District Office | Drug Quality Assurance |
| October 21, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 15, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for King Pharmaceuticals LLC
- FDA Inspection 1261579 - 2025-02-18
- FDA Inspection 1107986 - 2019-10-21
- FDA Inspection 1049269 - 2018-03-14
- FDA Inspection 1000037 - 2016-11-21
- FDA Inspection 926523 - 2015-05-15
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