FDA Inspection
Apothecary Pharma LLCApothecary Pharma LLC – FDA Inspection, Sep 2, 2026
Record Details
This FDA Inspection record concerns Apothecary Pharma LLC, with an inspection on September 2, 2026, issued by the Atlanta District Office, covering human drugs.
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ID · 1f4355c3-f5cd-40db-b021-bd05a21ca995
Inspection Facts
- Inspection number
- 1302708
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.67(b)Written procedures not established/followed
- FDCA 503B(a)(2)Bulk drug substances, cannot be used in compounding
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Other FDA inspections of Apothecary Pharma LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2025 | OAI | Atlanta District Office | Drug Quality Assurance |
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