Form FDA 483 · Issued 2026-02-13
Automated Ophthalmics, Inc. — FDA Form 483 Analysis
FEI: 3005906810 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Automated Ophthalmics, Inc. (FEI 3005906810) on 2026-02-13 following an inspection of its manufacturer operations in Maryland. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 314.80(c)(2)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Late submission of quarterly safety reports
Inspector Observation Language: "Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter. Specifically, observed during inspection of Automated Ophthalmics, Inc. on 2026-02-13."
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 #2 · 21 CFR 212.20(d)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Determination need for investigation
Inspector Observation Language: "When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not [determine the need for an investigation] [conduct an investigation] [take appropriate corrective actions] when necessary. Specifically, observed during inspection of Automated Ophthalmics, Inc. on 2026-02-13."
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.