Form FDA 483 · Issued 2026-03-23
Catalent CTS, LLC — FDA Form 483 Analysis
FEI: 3002929455 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Manufacturer) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Catalent CTS, LLC (FEI 3002929455) on 2026-03-23 following an inspection of its drug manufacturer operations in Missouri. The report documents 5 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 212.30(a)
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Orderly handling, prevention of mix-ups, prevention of contamination
Inspector Observation Language: "Your facilities are not adequate to ensure [the orderly handling of materials and equipment] [the prevention of mix-ups] [the prevention of contamination of equipment or product by substances, personnel, or environmental conditions] that could reasonably be expected to have an adverse effect on product quality. Specifically, observed during inspection of Catalent CTS, LLC on 2026-03-23."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #2 · 21 CFR 211.25(c)
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Inadequate number of personnel
Inspector Observation Language: "The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, observed during inspection of Catalent CTS, LLC on 2026-03-23."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #3 · 21 CFR 211.166(a)(4)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Testing in same container - closure system
Inspector Observation Language: "The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed. Specifically, observed during inspection of Catalent CTS, LLC on 2026-03-23."
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 #4 · 21 CFR 211.160(b)(4)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Calibration - at intervals, written program, remedial action
Inspector Observation Language: "The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals [in accordance with an established written program] [with provisions for remedial action in the event accuracy and/or precision limits are not met]. Specifically, observed during inspection of Catalent CTS, LLC on 2026-03-23."
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 #5 · 21 CFR 211.67(c)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Cleaning/maintenance records not kept
Inspector Observation Language: "Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, observed during inspection of Catalent CTS, LLC on 2026-03-23."
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.