Is a Form 483 the same as a Warning Letter?

No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

Where can I read the full Form 483?

The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.

What is an FDA Form 483?

A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.

Does this Form 483 mean BlendHouse Allerton LLC violated the law?

No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.

BlendHouse Allerton LLC — FDA Form 483 Inspection, February 20, 2025 (6 Citations)

FDA inspected BlendHouse Allerton LLC in Pennsylvania and issued a Form 483 listing 6 inspectional observations following an inspection that concluded 2025-02-20. FDA records classify BlendHouse Allerton LLC as a manufacturer. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

Key facts

Firm	BlendHouse Allerton LLC
FEI / inspection ID	1921383
Inspection end date	February 20, 2025
Citation count	6

What a Form 483 means

A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.

Citations explained

Observation 1 — Citation Text You approved and released for use an ingredient that was

Citation Text You approved and released for use an ingredient that was not manufac n ll'ed, packaged, labeled, or held under conditions to prevent adulteration. Observation Details S ifi 11 film approved and released the use of ingredient for use in manufacnui ng m an onnu a p r, that was not held er conditi ons to prevent adulteration. On 12 /27/2024, a tiuck load of pall ets of raw ingredients ·e received • • uded allets of ; l ot and Ipa ets o ; ot . our film received/approve re ease or use pall ets m e manufacnu - ·n of powder, a er 1 pallet of the shipment ) contained evidence of rodent activity inc u mg g excreta. After an initial evaluation, your film desti·oyed and rejected this 1 pallet while using all others in the shipment-p1ior to adequately investigating the root cause. Then on 1/ 13 /2025, a tiuck load of I pall ets raw.

Observation 2 — , and it 's "Suppo1ting Evidence and Relevance"

, and it 's "Suppo1ting Evidence and Relevance". Dlllin~ e fnm stated they will be receiving shipments from lllllllllllllll on 2/ 17 /2025 and on 2/18/2025. On both occasions we observed the fnm 's receiving. On 2/ 17/2025, Ms. Katleen E. Whitesell, Sr. Director of Food Safety stated that after a discussion with the Corporate over the weekend, they have decided to inspect (with - break down all allets u on receipt, this is only for shipments coming in from . On 2/ 19/2025, Ms. Whitesell stated the fnm will continue with this pallet break down up through Mar·ch 19 , 2025. On 2/ 17/2025, the fnm received from and no pests or pest activity were noted. We only obs~ (<lilt) on the pallet slips pe1taining to pallets numbers ..... . The bags on the bottom layer of the pallet were directly in contact with the shoe p1ints. Ms. Whitesell instructed the warehouse employees to hold these pallets until flllther.

Observation 3 — Citation Text You did not exclude pests from your food plant to

Citation Text You did not exclude pests from your food plant to protect against contamination of food. Observation Details Specifically, review of your pest management program from 1/16/2024- CUITent, indicated a fi nding of a dead mouse on 1/ 22 /2024 east of the QA Lab, seeing a live mouse in the . t baler on 12/3/2024, and catching mouse in a snap trap inside the Room on 12/15/2024. Moreover, there were rodent catches on the ex en or premises, notably, in November 2024, and in December 2024 there were 11 and 8 catches in traps on the exte1ior premises, respectively. Also,- lllrnntl ou ar·e investigating rodent activity fo und in raw mate1ial, . D •• • k thl h e fo und- otential bar orage s1 es a are ouse Room and War·ehouse . , y ave not en ac ions o eliminate all po en ia ar· orage ar·eas. - Citation Reference 21 CFR 117.35(c) Supporting Evidence and.

Observation 4 — Citation Text You did not maintain a building used in the manufacture

Citation Text You did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition. Observation Details - Specifically, on 2/14/2024, we observed on the floor of dryer level near diamond plate surfaces was peeling. Also, the floor under the has rust on the floor. This creates a harder to clean surface Last time the level I (b) -(b) (4) the exhaust fan, on multiple locations, rusty surfaces and the epoxy on the (b) (4) (b) (4) thus leading to potential harborage areas for pathogenic microorganisms. floor near the exhaust fan was swabbed was on 10/10/24, one swab near (b) (4) was collected. Moreover, you had 8 confirmed Cronobacter Sakazakii positive findings at level I (b) I (b) floor from 1/2/2024-2/6/2025. Also, you stated that the level floor under the (b) (4) has not been swabbed in the past year (1/2/2024-current). You had 4 confirmed Cronobacter findings at level I.

Observation 5 — Citation Text Your plant was not designed to facilitate maintenance and sanitary

Citation Text Your plant was not designed to facilitate maintenance and sanitary operations. 30

Observation 6 — Citation Text You did not include conti·ols for the process for a

Citation Text You did not include conti·ols for the process for a powdered infant fo1mu l a. Observation Details S ecifically, the baghouse differential ar·e not calibrated. You ) and replace the filters. However, they have not been calibrated to ensure they ar·e working properly to detect any issues with the baghouse that may potentially impact diyer efficiency. 31

BlendHouse Allerton LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to BlendHouse Allerton LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

Is a Form 483 the same as a Warning Letter?: No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
Where can I read the full Form 483?: The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
What is an FDA Form 483?: A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
Does this Form 483 mean BlendHouse Allerton LLC violated the law?: No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.

See if this 483 escalates to a warning letter — before your auditor asks.

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Full FDA history for BlendHouse Allerton LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2025). BlendHouse Allerton LLC — FDA Form 483 Inspection, February 20, 2025 (6 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-blendhouse-allerton-llc-2025-02-20-1921383

MLA

"BlendHouse Allerton LLC — FDA Form 483 Inspection, February 20, 2025 (6 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-blendhouse-allerton-llc-2025-02-20-1921383.

Chicago

Argus HQ Research. "BlendHouse Allerton LLC — FDA Form 483 Inspection, February 20, 2025 (6 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-blendhouse-allerton-llc-2025-02-20-1921383.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_blendhouse_allerton_llc_2025_02_20_1921383_2025,
  title = {BlendHouse Allerton LLC — FDA Form 483 Inspection, February 20, 2025 (6 Citations)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-blendhouse-allerton-llc-2025-02-20-1921383},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗