Form FDA 483 · Issued 2026-09-09
Greenwich Rx — FDA Form 483 Analysis
FEI: 3043120213 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Sterile and Non Sterile Drug Products) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to Greenwich Rx (FEI 3043120213) on 2026-09-09 following an inspection of its producer of sterile and non sterile drug products operations in Texas. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.192
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Investigations of discrepancies, failures
Inspector Observation Language: "There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. Specifically, observed during inspection of Greenwich Rx on 2026-09-09."
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 #2 · 21 CFR 211.67(a)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Cleaning / Sanitizing / Maintenance
Inspector Observation Language: "Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, observed during inspection of Greenwich Rx on 2026-09-09."
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 211.67(b)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Written procedures not established/followed
Inspector Observation Language: "Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, observed during inspection of Greenwich Rx on 2026-09-09."
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.