FDA Inspection
King Pharmaceuticals LLCKing Pharmaceuticals LLC – FDA Inspection, Jan 19, 2010
Record Details
This FDA Inspection record concerns King Pharmaceuticals LLC, with an inspection on January 19, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- King Pharmaceuticals LLC
- Inspection Date
- January 19, 2010
- Product Type
- Drugs
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ID · 6d18c07e-39c1-4d09-b4ca-4c7f5290b6d3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 638769
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.192Written record of investigation incomplete
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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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