FDA Inspection
SCA Pharmaceuticals, LLCSCA Pharmaceuticals, LLC – FDA Inspection, Mar 13, 2026
Record Details
This FDA Inspection record concerns SCA Pharmaceuticals, LLC, with an inspection on March 13, 2026, issued by the New England District Office, covering human drugs.
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ID · 773b2600-60d4-4309-a9a0-a301b9a67212
Inspection Facts
- Inspection number
- 1307176
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of SCA Pharmaceuticals, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2024 | VAI | New England District Office | Drug Quality Assurance |
| October 20, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 5, 2018 | Not classified | New England District Office | Drug Quality Assurance |
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