Form FDA 483 · Issued 2025-09-19
ProRx LLC — FDA Form 483 Analysis
FEI: 3022250654 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to ProRx LLC (FEI 3022250654) on 2025-09-19 following an inspection of its outsourcing facility operations in Pennsylvania. The report documents 5 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.56(c)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Written procedures lacking for use of pesticides etc.
Inspector Observation Language: "Written procedures are lacking for the use of [rodenticides] [insecticides] [fungicides] [fumigating agents] [cleaning and sanitizing agents] designed to prevent the contamination of [equipment] [components] [drug product containers] [closures] [packaging, labeling materials] [drug products]. Specifically, observed during inspection of ProRx LLC on 2025-09-19."
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 #2 · 21 CFR 211.160(b)(2)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
In-process sample representation/identification
Inspector Observation Language: "In-process samples are not [representative] [properly identified]. Specifically, observed during inspection of ProRx LLC on 2025-09-19."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #3 · 21 CFR 211.160(b)(4)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Test devices not meeting specifications
Inspector Observation Language: "Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used. Specifically, observed during inspection of ProRx LLC on 2025-09-19."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #4 · 21 CFR 211.170(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Drug product reserve containers
Inspector Observation Language: "Drug product reserve samples are not stored in [the same immediate container-closure system as the marketed product] [an immediate container-closure system that has essentially the same characteristics as the marketed product]. Specifically, observed during inspection of ProRx LLC on 2025-09-19."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #5 · 21 CFR 211.110(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Control procedures fail to include the following
Inspector Observation Language: "Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of mixing to assure uniformity and homogeneity] [dissolution time and rate] [clarity, completeness or pH of solutions]. Specifically,observed during inspection of ProRx LLC on 2025-09-19."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.