Form FDA 483 · Issued 2026-03-17
Atlantic Analytical Laboratories LLC — FDA Form 483 Analysis
FEI: 2246907 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Contract Testing Laboratory) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Atlantic Analytical Laboratories LLC (FEI 2246907) on 2026-03-17 following an inspection of its contract testing laboratory operations in New Jersey. The report documents 2 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 (2)
Observation #1 · 21 CFR 211.166(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Results not used for expiration dates, storage cond.
Inspector Observation Language: "Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates]. Specifically, observed during inspection of Atlantic Analytical Laboratories LLC on 2026-03-17."
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 211.111
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Establishment of time limitations
Inspector Observation Language: "Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. Specifically, observed during inspection of Atlantic Analytical Laboratories LLC on 2026-03-17."
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.