Form FDA 483 · Issued 2025-09-05
North American Custom Laboratories LLC — FDA Form 483 Analysis
FEI: 3014229024 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Sterile and Non Sterile Drug Products) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to North American Custom Laboratories LLC (FEI 3014229024) on 2025-09-05 following an inspection of its producer of sterile and non sterile drug products operations in Texas. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.160(b)(3)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Drug products-sampling procedures/specifications
Inspector Observation Language: "Laboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products. Specifically, observed during inspection of North American Custom Laboratories LLC on 2025-09-05."
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 211.170(b)(1)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Retention time of reserve samples, in general
Inspector Observation Language: "You did not retain reserve samples for drug products for one year after the expiration dates of the drug products. Specifically, observed during inspection of North American Custom Laboratories LLC on 2025-09-05."
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 211.188(b)(5)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
In-process and laboratory control results
Inspector Observation Language: "Batch production and control records do not include [in-process] [laboratory control] results for each batch of drug product produced. Specifically, observed during inspection of North American Custom Laboratories LLC on 2025-09-05."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #4 · 21 CFR 211.186(b)(8)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Description of containers, labels, et. al.
Inspector Observation Language: "Master production and control records lack [a description of the drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling] [the signatures and dates entered by the person or persons responsible for the approval of labeling]. Specifically, observed during inspection of North American Custom Laboratories LLC on 2025-09-05."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.
Observation #5 · 21 CFR 211.204
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Record information maintained
Inspector Observation Language: "Records of returned drug products are not maintained. Specifically, observed during inspection of North American Custom Laboratories LLC on 2025-09-05."
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.