FDA Inspection
BPI LabsBPI Labs – FDA Inspection, Mar 10, 2022
Record Details
This FDA Inspection record concerns BPI Labs, with an inspection on March 10, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- BPI Labs
- Inspection Date
- March 10, 2022
- Product Type
- Drugs
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ID · 371e8cca-6f7d-4d56-bb81-6effb37a5368
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1164737
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.188(b)(2)Identification of Equipment and Lines
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.84(b)Representative Samples Criteria
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of BPI Labs
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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