FDA Inspection
American Pharma Mfg. Inc.American Pharma Mfg. Inc. – FDA Inspection, Mar 27, 2026
Record Details
This FDA Inspection record concerns American Pharma Mfg. Inc., with an inspection on March 27, 2026, issued by the Los Angeles District Office, covering foods & cosmetics.
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ID · 9d04b615-d201-494a-83c0-992d68fe381f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1294900
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 111.12(b)Personnel - quality control operations; identified
- 21 CFR 111.15(c)(3)Cleaning compounds and toxic materials - holding
- 21 CFR 111.15(d)(1)Animals and pests in facility
- 21 CFR 111.210Master manufacturing record - record requirements
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.255(c)Batch record - each step
- 21 CFR 111.260Batch record - required information
- 21 CFR 111.30(c)Equipment - automated - calibrate, inspect
- 21 CFR 111.370Rejected dietary supplements - identify, hold, control
- 21 CFR 111.70(b)Specifications - components
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