FDA Inspection
SCA Pharmaceuticals, Inc.SCA Pharmaceuticals, Inc. – FDA Inspection, May 17, 2023
Record Details
This FDA Inspection record concerns SCA Pharmaceuticals, Inc., with an inspection on May 17, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bc538f3c-5f6b-4670-bd0d-9a31a765e5a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1205440
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of SCA Pharmaceuticals, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2025 | Not classified | Dallas District Office | Drug Quality Assurance |
| November 7, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 2, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SCA Pharmaceuticals, Inc.
- FDA Inspection 1281852 - 2025-10-30
- FDA Inspection 1111076 - 2019-11-07
- FDA Inspection 1027362 - 2017-09-29
- FDA Inspection 877947 - 2014-04-02
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