Form FDA 483 · Issued 2025-09-18
Biotechnologines farmacijos centras Biotechpharma UAB — FDA Form 483 Analysis
FEI: 3013580641 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Substance Manufacturer) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to Biotechnologines farmacijos centras Biotechpharma UAB (FEI 3013580641) on 2025-09-18 following an inspection of its drug substance manufacturer operations in Lithuania. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.160(b)(3)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Sampling/testing of drug products
Inspector Observation Language: "The specifications for drug products are deficient in that they do not include a description of the [sampling plan] [testing procedures] for drug products. Specifically, observed during inspection of Biotechnologines farmacijos centras Biotechpharma UAB on 2025-09-18."
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 #2 · 21 CFR 211.170(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Active ingredient retained sample kept
Inspector Observation Language: "A sample which is representative of each lot in each shipment of each active ingredient is not [appropriately identified] [retained]. Specifically, observed during inspection of Biotechnologines farmacijos centras Biotechpharma UAB on 2025-09-18."
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 #3 · 21 CFR 211.84(d)(3)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Testing Containers & Closures Conformity with Specs
Inspector Observation Language: "Containers and closures are not tested for conformance with all appropriate written procedures. Specifically, observed during inspection of Biotechnologines farmacijos centras Biotechpharma UAB on 2025-09-18."
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 211.122(a)
Label Control, Undeclared Allergens & Structure/Function Claims
REPEAT CITATION AT FACILITY
Written procedures not followed
Inspector Observation Language: "Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed. Specifically, observed during inspection of Biotechnologines farmacijos centras Biotechpharma UAB on 2025-09-18."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.
Observation #5 · 21 CFR 211.160(b)(3)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Drug products-sampling procedures/specifications
Inspector Observation Language: "Laboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products. Specifically, observed during inspection of Biotechnologines farmacijos centras Biotechpharma UAB on 2025-09-18."
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.