What happens after a Form 483 is issued?

The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.

Has Boothwyn Pharmacy LLC had other FDA inspection citations?

Yes. Argus HQ has recorded 2 total FDA actions tied to Boothwyn Pharmacy LLC, including 2 Form 483 inspection citations.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 1000076625.

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.

FDA Form 483 — Boothwyn Pharmacy LLC (October 22, 2024)

Key facts

Firm	Boothwyn Pharmacy LLC
FEI / inspection ID	1000076625
Inspection end date	October 22, 2024
Citation count	1

The short version: FDA inspected Boothwyn Pharmacy LLC in Pennsylvania and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2024-10-22. FDA records classify Boothwyn Pharmacy LLC as a producer of sterile and non sterile drug products. 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.

Citations explained

Observation 1 — DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PH ONE NUMBER us Customhouse Rrn900 200 Chestnut St Philadelphia, PA 19106 (21 5)597 - 4 390 Ext:4200 Fax: (21 5)597 - 0875 ORAPHARM l _ RESPO NSES@fda . hhs . gov OATE(S) OF INSPECTION 9/23/202 4- 1 0/22/202 4* FEJNUMBER 1 000076625 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED John W. Howell Sr . , Execcutive Vice President of Opera ti ons FIRM NAME Boothwyn Pharmacy LLC STREET ADDRESS 221 Gale Ln CITY . STATE. ZIP CODE. COUITTRY Kennett Square, PA 1 9348 TYPE ESTABUSHMENT INSPECTED Producer of S teri le and Non - S teri le Drug Products This document lists observations made by the FDA representa

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.

Boothwyn Pharmacy LLC’s FDA history

Argus HQ has recorded 2 total FDA actions tied to Boothwyn Pharmacy LLC: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.

Frequently asked questions

What happens after a Form 483 is issued?: The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
Has Boothwyn Pharmacy LLC had other FDA inspection citations?: Yes. Argus HQ has recorded 2 total FDA actions tied to Boothwyn Pharmacy LLC, including 2 Form 483 inspection citations.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 1000076625.
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.

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

Free weekly briefing tracks every FDA inspection outcome.

Full FDA history for Boothwyn Pharmacy 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 (2024). FDA Form 483 — Boothwyn Pharmacy LLC (October 22, 2024) — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-boothwyn-pharmacy-llc-2024-10-22-1000076625

MLA

"FDA Form 483 — Boothwyn Pharmacy LLC (October 22, 2024) — 1 Citations." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-boothwyn-pharmacy-llc-2024-10-22-1000076625.

Chicago

Argus HQ Research. "FDA Form 483 — Boothwyn Pharmacy LLC (October 22, 2024) — 1 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-boothwyn-pharmacy-llc-2024-10-22-1000076625.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_boothwyn_pharmacy_llc_2024_10_22_1000076625_2024,
  title = {FDA Form 483 — Boothwyn Pharmacy LLC (October 22, 2024) — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-boothwyn-pharmacy-llc-2024-10-22-1000076625},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗