CHARGE CODE: INSANITARY_CONDITIONSFD&C Act Section 402(a)(4) / 501(a)(2)(A)Severity Weight: 9/10

✕ Form FDA 766 Relabeling Ineligible

Adulterated: Prepared, packed, or held under insanitary conditions whereby it may have become contaminated

Statutory & CFR Citation: 21 U.S.C. § 342(a)(4) (Food/Supplement) • 21 U.S.C. § 351(a)(2)(A)-(B) (Drug/cGMP) • Associated Import Alert 66-40 / Import Alert 99-39

Plain-English Importer Translation:

An FDA foreign inspection (Form FDA 483) or cGMP audit found systemic facility sanitation failures, non-sterile ophthalmic/OTC water systems, or pest harborage.

Typical Port Detention Window

30–60+ calendar days

Estimated Defense / Lab Cost

$8,500 – $22,000 (cGMP CAPA remediation & Import Alert petition)

Primary Import Alert Trigger

Import Alert 66-40 / Import Alert 99-39

Form FDA 766 Relabeling / Reconditioning Playbook

NOT ELIGIBLE FOR FORM 766 OR SINGLE-LOT LAB RELEASE WHEN UNDER cGMP IMPORT ALERT 66-40: Because Section 402(a)(4) / 501(a)(2)(A) means the product 'may have become contaminated' due to systemic plant conditions, finished-product testing alone usually cannot overcome a cGMP Import Alert 66-40 detention.

Step-by-Step CBP & FDA ITACS Response Sequence:

1Determine immediately whether detention stems from a facility-wide Form FDA 483 / Warning Letter (Import Alert 66-40 or 99-39) or a container-level sanitation failure.
2If facility-wide cGMP DWPE applies, demand the factory's Establishment Inspection Report (EIR) and CAPA closure documentation before paying any remaining supplier invoices.
3For sterile ophthalmic/OTC products, commission USP <71> Sterility and USP <85> Bacterial Endotoxins testing while counsel negotiates with CDER Office of Manufacturing Quality.
4File a formal Import Alert Removal Petition once third-party cGMP re-inspection confirms all Form 483 observations are closed.

Private Lab Packet (PLAP) & Importer Checklist

Required Analytical / Regulatory Protocol:

Third-party cGMP / 21 CFR 211 / 21 CFR 111 on-site mock FDA audit + USP <71> Sterility / USP <61> Microbial Enumeration.

Pre-Shipment & Post-Detention Verification Checklist:

Obtain the overseas manufacturer's full Form FDA 483 Establishment Inspection Report (EIR) and CAPA response timeline.
Verify whether the facility has been placed on Import Alert 66-40 (cGMP Drug/OTC) or 99-39 before shipping additional containers.
Retain US FDA regulatory counsel to submit an independent cGMP verification audit and petition for removal from DWPE.

Historical OASIS Enforcement Precedents

Overseas Suppliers Cited for INSANITARY_CONDITIONS (1)

Ahmedabad, Gujarat, India • FEI 3015092811

Ahmedabad Sterile Ophthalmics & Pharma Ltd.

100/100

Entry #E12-4581920-4 (2026-09-08)Port: Newark

Preservative-Free Lubricant Eye Drops 0.5% (30 Single-Use Vials)

Disposition: Refused & Exported • Value: $215,000

Entry #M52-7410293-5 (2026-02-11)Port: Miami

Pediatric Hypertonic Xylitol Nasal Mist

Disposition: Refused & Exported • Value: $78,500

Ophthalmic Drops, Nasal Sprays & OTC Monograph Drugs Full Supplier Dossier

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21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab

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Instant Supplier Detention Webhook & Email Alert Monitor

Get an automated Slack/Webhook JSON payload and email alert within 15 minutes whenever FDA OASIS logs a new detention, Import Alert Red List addition, or Warning Letter for Ahmedabad Sterile Ophthalmics & Pharma Ltd. before you wire your 70% balance payment.

TIER 3 • URGENT US FDA COMPLIANCE COUNSEL DISPATCH (CPL VERIFIED)

Respond-By Deadline Priority Triage

Shipment Detained by FDA or Placed on Import Alert? Request Free 24h Detention Evaluation from Licensed US FDA Compliance Counsel

When FDA issues a Notice of FDA Action (Detention), importers typically have only 10 to 20 business days to file a Form FDA 766 relabeling application, submit an accredited private laboratory packet (PLAP), or petition for Import Alert Red List removal before CBP orders refusal and liquidated damages.

Your Full Name & Role (Required)

Include your name and title (e.g., “Sarah Chen, VP Supply Chain”).

Please provide your full name (at least 2 characters).

Work Email for 24h Legal Memo (Required)

Used strictly to deliver your conflict-free 24h FDA detention evaluation.

Please enter a valid corporate email address.

Importer Website or Amazon/Shopify Store URL (Required)

Include https:// so counsel can pre-screen product Intended Use claims.

Please enter a valid URL starting with https:// or http://.

CBP Entry Number or Supplier FEI # (Required)

Format: 10-digit FEI (e.g., 3015092811) or 11-char CBP Entry # (e.g., W94-8829104-3).

Enter a 5–24 character alphanumeric FEI number or CBP Entry number.

US Port of Detention

Select the FDA District / Port holding the cargo.

Primary Cited FDA Charge Code

Charge listed on your Notice of FDA Action.

Commercial Cargo Value at Risk

Determines Form 766 vs. PLAP economic viability.

Notice of FDA Action Summary & Respond-By Date (Optional)

Describe whether cargo is currently on hold in ITACS, whether private lab sampling has started, or if you need an Import Alert removal petition.

🔒 Confidential submission • Zero upfront cost for 24h detention evaluation • Matched with licensed US FDA / Customs attorneys.

Charge Code INSANITARY_CONDITIONS FAQ

What does FDA Charge Code INSANITARY_CONDITIONS (FD&C Act Section 402(a)(4) / 501(a)(2)(A)) mean on a Notice of FDA Action?

Adulterated: Prepared, packed, or held under insanitary conditions whereby it may have become contaminated. In plain English: An FDA foreign inspection (Form FDA 483) or cGMP audit found systemic facility sanitation failures, non-sterile ophthalmic/OTC water systems, or pest harborage.