Form 483 Library → The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories → 483-1818658-20260320
Form FDA 483 · Issued 2026-03-20
The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories — FDA Form 483 Analysis
FEI: 1818658 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Regulated Products) · Lead Investigator: David K. Chen
FDA Form 483 issued to The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories (FEI 1818658) on 2026-03-20 following an inspection of its producer of regulated products operations in Tennessee. The report documents 4 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.67(b)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Written procedures fail to include
Inspector Observation Language: "Written procedures for cleaning and maintenance fail to include [assignment of responsibility] [maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and materials used] [description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or obliteration of previous batch identification] [instructions for protection of clean equipment from contamination prior to use] [parameters relevant to the operation]. Specifically, observed during inspection of The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories on 2026-03-20."
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 #2 · 21 CFR 212.30(b)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Equipment procedures
Inspector Observation Language: "You did not [implement procedures] [document your activities in accordance with your procedures] to ensure that all equipment is [cleaned] [suitable for its intended purposes] [properly installed, maintained, and capable of repeatedly producing valid results] that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained. Specifically, observed during inspection of The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories on 2026-03-20."
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.
Observation #3 · 21 CFR 211.42(c)(5)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Mfg / Processing Operations Area
Inspector Observation Language: "Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations. Specifically, observed during inspection of The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories on 2026-03-20."
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 #4 · 21 CFR 211.198(b)(2)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Complaint Investigation/Follow-Up Findings
Inspector Observation Language: "Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up]. Specifically, observed during inspection of The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories on 2026-03-20."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.