Form FDA 483 · Issued 2026-01-29
Prof. Bernardo Leon Rapaport — FDA Form 483 Analysis
FEI: 3021927419 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Clinical Investigator) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Prof. Bernardo Leon Rapaport (FEI 3021927419) on 2026-01-29 following an inspection of its clinical investigator operations in South Africa. The report documents 5 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.186(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Signature and checking of records -- 2 persons
Inspector Observation Language: "The master production and control records for each batch size of drug product are not [prepared, dated, and signed by one person with a full handwritten signature] [independently checked, dated, and signed by a second person]. Specifically, observed during inspection of Prof. Bernardo Leon Rapaport 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 211.188(b)(11)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Identification of Persons Performing Significant Steps
Inspector Observation Language: "The batch production and control records are deficient in that they do not include identification of persons [performing] [supervising] [checking] each significant step in the operation. Specifically, observed during inspection of Prof. Bernardo Leon Rapaport 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 #3 · 21 CFR 211.194(a)(6)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Comparison of Test Results to Specifications
Inspector Observation Language: "Laboratory records are deficient in that they do not include a statement of the results of tests and how they compare to the established [specifications] [standards]. Specifically, observed during inspection of Prof. Bernardo Leon Rapaport 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.
Observation #4 · 21 CFR 211.56(b)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Written sanitation procedures lacking
Inspector Observation Language: "There is a lack of written procedures [assigning responsibility] [providing cleaning schedules] [describing in sufficient detail the methods, equipment and materials to be used] for sanitation. Specifically, observed during inspection of Prof. Bernardo Leon Rapaport on 2026-01-29."
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 #5 · 21 CFR 211.105(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
REPEAT CITATION AT FACILITY
Identification of containers, lines, equipment
Inspector Observation Language: "All [compounding and storage containers] [processing lines] [major equipment] used during the production of a batch of drug product is not properly identified at all times to indicate [contents] [the phase of processing of the batch]. Specifically, observed during inspection of Prof. Bernardo Leon Rapaport 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.