FDA Inspection
SCA Pharmaceuticals, LLCSCA Pharmaceuticals, LLC – FDA Inspection, Dec 20, 2024
Record Details
This FDA Inspection record concerns SCA Pharmaceuticals, LLC, with an inspection on December 20, 2024, issued by the New England District Office, covering human drugs.
View Company Profile
ID · 5b183fe0-2abd-41cf-9bcd-aa227ebda39a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1252093
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.63Equipment Design, Size and Location
- 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
- 21 CFR 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
Other documents for SCA Pharmaceuticals, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.