Form FDA 483 · Issued 2026-03-06
Saptalis Pharmaceuticals LLC — FDA Form 483 Analysis
FEI: 3012152381 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Product Manufacturer) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to Saptalis Pharmaceuticals LLC (FEI 3012152381) on 2026-03-06 following an inspection of its drug product manufacturer operations in New York. The report documents 5 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.165(d)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Acceptance criteria for sampling & testing
Inspector Observation Language: "Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet [each appropriate specification] [appropriate statistical quality control criteria] as a condition for their approval and release. Specifically, observed during inspection of Saptalis Pharmaceuticals LLC on 2026-03-06."
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 211.142
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Written warehousing procedures established/followed
Inspector Observation Language: "Procedures describing the warehousing of drug products are not [established] [followed]. Specifically, observed during inspection of Saptalis Pharmaceuticals LLC on 2026-03-06."
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 · FDCA 501(a)(2)(A)
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination
Inspector Observation Language: "[Beta-lactam drugs] [Hazardous drugs] [Highly potent drugs] were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination. Specifically, observed during inspection of Saptalis Pharmaceuticals LLC on 2026-03-06."
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 #4 · 21 CFR 211.130
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Procedures are written, and followed
Inspector Observation Language: "Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed]. Specifically, observed during inspection of Saptalis Pharmaceuticals LLC on 2026-03-06."
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 211.84(e)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Rejecting When Specifications Not Met
Inspector Observation Language: "Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the appropriate written specifications for identity, strength, quality, and purity. Specifically, observed during inspection of Saptalis Pharmaceuticals LLC on 2026-03-06."
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.