Form FDA 483 · Issued 2025-09-18
Petscript Inc — FDA Form 483 Analysis
FEI: 3010282564 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Sterile and Non Sterile Drug Products) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to Petscript Inc (FEI 3010282564) on 2025-09-18 following an inspection of its producer of sterile and non sterile drug products operations in Texas. The report documents 4 inspection observations centered on Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.160(b)(2)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
In-process sample representation/identification
Inspector Observation Language: "In-process samples are not [representative] [properly identified]. Specifically, observed during inspection of Petscript Inc on 2025-09-18."
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 211.160(b)(4)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Test devices not meeting specifications
Inspector Observation Language: "Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used. Specifically, observed during inspection of Petscript Inc on 2025-09-18."
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 #3 · 21 CFR 211.170(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Drug product reserve containers
Inspector Observation Language: "Drug product reserve samples are not stored in [the same immediate container-closure system as the marketed product] [an immediate container-closure system that has essentially the same characteristics as the marketed product]. Specifically, observed during inspection of Petscript Inc on 2025-09-18."
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 211.110(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Control procedures fail to include the following
Inspector Observation Language: "Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of mixing to assure uniformity and homogeneity] [dissolution time and rate] [clarity, completeness or pH of solutions]. Specifically,observed during inspection of Petscript Inc on 2025-09-18."
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.