FDA Inspection
K.C. Pharmaceuticals, IncK.C. Pharmaceuticals, Inc – FDA Inspection, Dec 30, 2009
Record Details
This FDA Inspection record concerns K.C. Pharmaceuticals, Inc, with an inspection on December 30, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- K.C. Pharmaceuticals, Inc
- Inspection Date
- December 30, 2009
- Product Type
- Drugs
View Company Profile
ID · a6388384-5163-4de4-a110-e8de53453bd9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 637086
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.160(b)(4)Written calibration procedures
- 21 CFR 211.192Written record of investigation incomplete
Showing 10 of 11 citations.
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Other FDA inspections of K.C. Pharmaceuticals, Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| August 28, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 13, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 30, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 16, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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