FDA Inspection
K.C. Pharmaceuticals, IncK.C. Pharmaceuticals, Inc – FDA Inspection, Feb 14, 2011
Record Details
This FDA Inspection record concerns K.C. Pharmaceuticals, Inc, with an inspection on February 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- K.C. Pharmaceuticals, Inc
- Inspection Date
- February 14, 2011
- Product Type
- Devices
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ID · 5fa2190c-0676-490a-aa8f-ac4801f1232c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 711197
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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