FDA Inspection
SCA Pharmaceuticals, LLCSCA Pharmaceuticals, LLC – FDA Inspection, Mar 5, 2018
Record Details
This FDA Inspection record concerns SCA Pharmaceuticals, LLC, with an inspection on March 5, 2018, issued by the New England District Office, covering human drugs.
- People
- Dien N. Nguyen (Issuing Officer)
- Jonathan G. Matrisciano (FDA Associated Person)
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ID · c77f4f1b-2415-4915-961c-1c7c4adf9bb5
Inspection Facts
- Inspection number
- 1043107
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
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Other FDA inspections of SCA Pharmaceuticals, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2026 | Not classified | New England District Office | Drug Quality Assurance |
| December 20, 2024 | VAI | New England District Office | Drug Quality Assurance |
| October 20, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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