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

FEI / inspection ID: 3011430551.

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.

July 10, 2026 FDA Form 483 for Brookfield Medical Surgical Supplies Inc

FDA inspected Brookfield Medical Surgical Supplies Inc in Connecticut and issued a Form 483 listing 4 inspectional observations following an inspection that concluded 2026-07-10. FDA records classify Brookfield Medical Surgical Supplies Inc 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.

Key facts

Firm	Brookfield Medical Surgical Supplies Inc
FEI / inspection ID	3011430551
Inspection end date	July 10, 2026
Citation count	4

Citations explained

Observation 1 — There is a failure to thoroughly review any unexplained discrepancy and the failure of a

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. Specifically, Your firm failed to adequately investigate Out-of-Specification (OOS) results fo r potency testing of sterile drug products manufactured during May 2024-June 2026. A review of deviation records revealed thirteen (13) OOS potency failures across multiple drug products and lots, indicates a recurring and systemic failure to maintain adequate process controls. All 00S were reportedly attributed to the contract testing laboratory and resolved via retesting at the same lab. Table below shows all the potency OOS: Deviation # Date Initiated Type Drug Product Lot Number(s) Close Date Vials DV24·051 Se ptember 19,2024 OO S Potency Tr ia mcinolone Ace tonide 091124·1 October 4, 2024 (b) (4 ) DV25-053 April 3, 2025 OO S Poten cy M orph ine Sulfat e 032625-1 Ap ril 9, 2025 DV25-054 April 7, 2025 OO S Methylprednisolon 033125-1 April 14, EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Sangee t a M Khurana, I nves t iga t or - GDUFA SANGE 7/ 1 0/2026 OF THIS PAGE ETA M. :;:=:;:

Observation 2 — The responsibilities and procedures applicable to the quality control unit are not fully

The responsibilities and procedures applicable to the quality control unit are not fully fo llowed. Specifically, Your quality control unit failed to exercise adequate oversight of the contract testing laboratory performing potency testing (refer to the table in

Observation 1 — ) as evidenced b y: (1) Pattern of OOS invalidation without adequate QCU scrutiny

) as evidenced b y: (1) Pattern of OOS invalidation without adequate QCU scrutiny Thirteen (13) Out-of-Specification (OOS) potency results were recorded over 26 months between May 2024 and June 2026 across four drug products (Triamcinolone Acetonide, Betamethasone Sodium Phosphate, Methylprednisolone Acetate, and Morphine Sulfate). Twelve (1 2) of these OOS results were invalidated and product was released without documented evidence that the quality control unit independently reviewed the contract laboratory's raw data, chromatograms, instrument logs and invalidation rationale. EM PLOYEE(S) SIGNATURE DAT E ISSUED SEEREVERSE Sa ng eeta M Kh u ra n a, I n ve s ti g at o r - GDU FA SANGE 7/ 1 0/2026 OF THIS PAGE ETA M. :;:=:;: M. t<HJ~.S KHURA -""'"·" X NA ~S 1221;41..o,,w FORM FDA 483 ( 09/08) PAGE 3 of6 PAGES PREVIOUS EDmON OBSOLim! INSPECTIONAL OBSERVATIONS -- 3 of 7 -- DEPART!\fi:NT OF HEALTH Al~ HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS A NO PHONE NUMBER DATE(S) OF I NSPECTI ON 109 Hol t on Street 6/29/2026 - 7/ 1 0/2026 * Wi nc he s ter, MA 01 890 FEI NUMBER 3011 43 0551(7 81) 5 87- 75 00 Fax : (781 )58 7- 7 556 NAME ANO TITLE OF INDIVIDUAL TO WH OM REPORT IS

Observation 3 — Procedures designed to prevent microbiological contaminati on of drug products purporting

Procedures designed to prevent microbiological contaminati on of drug products purporting to be sterile are n ot followed. Specifically, The environmental monitoring program of your firm allows for a CFU limit (lj 4 for gloved fingertips in an ISO 5 area. For a COMP compliant 503B facility, the action level must be any detected organism. Furthermore, your firm failed to investigate and identity the microbial growth recovered from the ISO 5 environment at the facility. All the compounded drug products were released for distribution. The environmental monitoring (EM) excursion records below document nine (9) microbial excursions occurring in ISO-5 classified areas between May 8, 2025, and June 24, 2026. Of these, five (5) involved gloved fingertip samples, three (3) involved personne](b) (4) samples, and one (1) involved a surface sample. All samples yielded 1 CFU on (lj 4) ), exceeding the action level o fl 6l 1"1CFU established for ISO-5 areas. Only one excursion (No. 39, dated 2026-05-21) which involved a surface sample from location ISO-sJ''H• was identified as a Bacillus Species. No other microbial excursions from ISO 5 environment were isolated and identified. Microorganism 14

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.

Brookfield Medical Surgical Supplies Inc’s FDA history

Argus HQ has recorded 1 total FDA action tied to Brookfield Medical Surgical Supplies Inc: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3011430551.
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.

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 Brookfield Medical Surgical Supplies Inc

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). July 10, 2026 FDA Form 483 for Brookfield Medical Surgical Supplies Inc — 4 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/brookfield-medical-surgical-supplies-3011430551-2026-07-10

MLA

"July 10, 2026 FDA Form 483 for Brookfield Medical Surgical Supplies Inc — 4 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/brookfield-medical-surgical-supplies-3011430551-2026-07-10.

Chicago

Argus HQ Research. "July 10, 2026 FDA Form 483 for Brookfield Medical Surgical Supplies Inc — 4 Citations." Digital Empire Holdings LLC. Accessed September 11, 2026. https://argushq.ai/483/brookfield-medical-surgical-supplies-3011430551-2026-07-10.

BibTeX

@misc{argushq_argushq_ai_483_brookfield_medical_surgical_supplies_3011430551_2026_07_10_2026,
  title = {July 10, 2026 FDA Form 483 for Brookfield Medical Surgical Supplies Inc — 4 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/brookfield-medical-surgical-supplies-3011430551-2026-07-10},
  note = {Accessed: September 11, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗