Form FDA 483 · Issued 2025-11-11
Loba biotech GmbH — FDA Form 483 Analysis
FEI: 3002807485 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Substance Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Loba biotech GmbH (FEI 3002807485) on 2025-11-11 following an inspection of its drug substance manufacturer operations in Austria. The report documents 3 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Cleaning Validation, Sanitation Logs & Pest Control.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.165(c)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Sampling and testing plans not described
Inspector Observation Language: "Sampling and testing plans for drug products are not described in written procedures which include the [method of sampling] [number of units per batch to be tested]. Specifically, observed during inspection of Loba biotech GmbH on 2025-11-11."
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 211.182
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Personnel dating/signing equipment log
Inspector Observation Language: "The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log. Specifically, observed during inspection of Loba biotech GmbH on 2025-11-11."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #3 · 21 CFR 211.188(b)(10)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Documentation of Sampling Performed
Inspector Observation Language: "The batch production and control records are deficient in that they do not include documentation of sampling performed. Specifically, observed during inspection of Loba biotech GmbH on 2025-11-11."
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.