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 Right Value Drug Stores 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.

What happens after a Form 483 is issued?

Argus HQ has recorded 2 total FDA actions tied to Right Value Drug Stores LLC. The firm typically has 15 business days to submit a written response describing planned corrections; unresolved or serious findings can lead to a Warning Letter or other enforcement action.

Right Value Drug Stores LLC — FDA Form 483 Inspection, September 8, 2026 (4 Citations)

Key facts

Firm	Right Value Drug Stores LLC
FEI / inspection ID	3010589333
Inspection end date	September 8, 2026
Citation count	4

The short version: FDA inspected Right Value Drug Stores LLC in Texas and issued a Form 483 listing 4 inspectional observations following an inspection that concluded 2026-09-08. FDA records classify Right Value Drug Stores LLC as a outsourcing facility. 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. 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 — Procedures designed to prevent microbiological contamination of diug products pmpo1ting

Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile are not followed. Specifically, your fnm failed to p erfo1m adequate smoke study videos of the biological safety cabinets (BSC) in room (6) (4Y in a dynamic state to demonstrate unidirectional airflow and proper environmental controls during actual operating conditions. Your cmTent practice is to p erfo1m aseptic filling operations in room 4 (ll) (41with b) < > BSCs ~(b) (4) Ioperating simultaneously. However, the smoke study videos provided, titl ed "Workers 4 l DJ l J ISO 5 Hood During Fill," did n ot demonstrate that: • Unidirectional airflow is maintained during simultaneous operation oflb) <-"J BSCs • Air patterns prevent contamination of critical surfaces • Personnel movements and interventions do n ot disrnpt the aseptic environment This is a repeat observation.

Observation 2 — Laborato1y controls do not include the establishment of scientifically sound and

Laborato1y controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that diug products confo1m to appropriate standards of identity, strength, quality and purity. Specifically, Your he fnm fails to per fo1m dissolution testing and hardness/friability testing as pait of estradiol pellets batch release. The specification and batch release criteria are limited to potency assay and endotoxin testing. Since 06/01/2025 through this inspection period, approximately 260 of the r n4j EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Milton J De Jesus Tavarez, I nves ti ga t or 9/8/2026 OF THIS PAGE Nije A Thomas, I nves ti ga t or Ybt -J Oll'JtS14nw.-cz St,,ecf9,: ..l1'0NJ. DE JESUS-TAVMEZ-8 X O.a:,,e,:tCl9-c.2026 12:Sol:13 FORM FDA ~83 (09/08) INS PEC TIONAL OB SERVATIONS PAGE I of5 PAGES PREVIOUS EDmON OBSOLEJE -- 1 of 6 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION D ISTRI CT ADDRESS ANO PH ONE NUMBER OATE(S) OF INSPEC TION 1 20 1 Mai n S treet, S uite 7 200 8/2 4 /2026 - 9/8/2026 * Da ll a s , TX 7 5202 F EJNUMBER 30 1 0 5 89333 (21 4 )2 5 3 - 5 200 Fax: (21 4 )2 5 3 - 5 31 4 NAME AND T ITLE OF INDIVIDUAL T

Observation 5 — Aseptic process ing areas are deficient regarding the system for monitoring environmental

Aseptic process ing areas are deficient regarding the system for monitoring environmental conditions. Specifically, your fnm failed to perfo1m environmental monitoring as requir ed in SOP 4.090, Environmental and Personnel Monitorin~ Program, version 7, section 7 .1. This includes data, and evaluation support ing continuous ~b) ~ non-viable paiiicle sampling in ISO 5 and ISO 7 ar eas, regardless of batch manufacturing activities.

Observation 6 — Te st devices are deficient in that instmments not meeting establish ed specifications

Te st devices are deficient in that instmments not meeting establish ed specifications are used. Specifically, analytical balance 1(0) (4)J calibrations and/or 4 (6J < i verifications do not cover the full bracketed range of use fo r the pellet process weights (6) (2J) to [(6) (.2J) IFor example: • Analytical balance 19-00003 (serial [{Q) (2J) ) was calibrated on 04/ 13 /2026 at (o) (4) to [(b) (4 . This balance is used for the pellet compounding process in (o) (4) This is a repeat observation *DATES OF INSPECTION 8/24/2026(Mon), 8/25/2026(Tue), 8/26/2026(Wed), 8/27/2026(Thu), 8/28/2026(Fri), 8/31/2026(Mon), 9/0 l/2026(Tue), 9/02/2026(Wed), 9/ 03 /2026(Thu), 9/04/2026(Fri), 9/08/2026(Tue) SEE REVERSE OF THIS PAGE EMPLOYEE(S) SIGNATURE Milton J De Jesus Tavarez, I nves ti ga t o r Nije A T homas , I nves ti ga t o r DATE ISSUED 9/8/2026 -- 5 of 6 -- The observations of objectionable conditions and practices listed on the front of this form are reported: 1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration. Section 704(b) of the Federal Food, Dr

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.

Right Value Drug Stores, LLC’s FDA history

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

Frequently asked questions

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 Right Value Drug Stores 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.
What happens after a Form 483 is issued?: Argus HQ has recorded 2 total FDA actions tied to Right Value Drug Stores LLC. The firm typically has 15 business days to submit a written response describing planned corrections; unresolved or serious findings can lead to a Warning Letter or other enforcement action.

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Full FDA history for Right Value Drug Stores, 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 (2026). Right Value Drug Stores LLC — FDA Form 483 Inspection, September 8, 2026 (4 Citations). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/right-value-drug-stores-3010589333-2026-09-08

MLA

"Right Value Drug Stores LLC — FDA Form 483 Inspection, September 8, 2026 (4 Citations)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/right-value-drug-stores-3010589333-2026-09-08.

Chicago

Argus HQ Research. "Right Value Drug Stores LLC — FDA Form 483 Inspection, September 8, 2026 (4 Citations)." Digital Empire Holdings LLC. Accessed October 12, 2026. https://argushq.ai/483/right-value-drug-stores-3010589333-2026-09-08.

BibTeX

@misc{argushq_argushq_ai_483_right_value_drug_stores_3010589333_2026_09_08_2026,
  title = {Right Value Drug Stores LLC — FDA Form 483 Inspection, September 8, 2026 (4 Citations)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/right-value-drug-stores-3010589333-2026-09-08},
  note = {Accessed: October 12, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗