FDA Inspection
Purechempros LLCPurechempros LLC – FDA Inspection, Nov 22, 2022
Record Details
This FDA Inspection record concerns Purechempros LLC, with an inspection on November 22, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Purechempros LLC
- Inspection Date
- November 22, 2022
- Product Type
- Drugs
View Company Profile
ID · 4be42649-2896-48a1-8c4d-d50c457f668e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1191179
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.100(a)Absence of Written Procedures
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