Form FDA 483 · Issued 2026-01-29
Apotek Production & Laboratorier AB — FDA Form 483 Analysis
FEI: 3003766921 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Drug Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Apotek Production & Laboratorier AB (FEI 3003766921) on 2026-01-29 following an inspection of its sterile drug manufacturer operations in Sweden. The report documents 2 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.188(b)(7)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Documentation of Actual Yield and Theoretical Yield
Inspector Observation Language: "The batch production and control records are deficient in that they do not include a statement of the [actual yield] [percentage of theoretical yield]. Specifically, observed during inspection of Apotek Production & Laboratorier AB on 2026-01-29."
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 211.194(d)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Laboratory equipment calibration records
Inspector Observation Language: "Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices]. Specifically, observed during inspection of Apotek Production & Laboratorier AB on 2026-01-29."
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.