Form FDA 483 · Issued 2026-04-17
BPI Labs, LLC — FDA Form 483 Analysis
FEI: 3015156709 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to BPI Labs, LLC (FEI 3015156709) on 2026-04-17 following an inspection of its outsourcing facility operations in Florida. The report documents 5 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.180(e)(1)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Review of representative number of batches
Inspector Observation Language: "Written procedures are not [established] [followed] for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. Specifically, observed during inspection of BPI Labs, LLC on 2026-04-17."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #2 · 21 CFR 211.22(c)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Approve or reject procedures or specs
Inspector Observation Language: "The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting on the [identity] [strength] [quality] [purity] of drug products. Specifically, observed during inspection of BPI Labs, LLC on 2026-04-17."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #3 · 21 CFR 211.137(a)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Expiration date lacking
Inspector Observation Language: "Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. Specifically, observed during inspection of BPI Labs, LLC on 2026-04-17."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #4 · 21 CFR 211.84(d)(1)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Component identity verification
Inspector Observation Language: "Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. Specifically,observed during inspection of BPI Labs, LLC on 2026-04-17."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #5 · 21 CFR 211.68(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
input/output verification
Inspector Observation Language: "Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, observed during inspection of BPI Labs, LLC on 2026-04-17."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.