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

FEI / inspection ID: 3009724085.

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.

OPS International Inc dba Olympia Pharmaceuticals — FDA Form 483 Inspection, September 3, 2026 (8 Citations)

Key facts

Firm	OPS International Inc dba Olympia Pharmaceuticals
FEI / inspection ID	3009724085
Inspection end date	September 3, 2026
Citation count	8

The short version: FDA inspected OPS International Inc dba Olympia Pharmaceuticals in Florida and issued a Form 483 listing 8 inspectional observations following an inspection that concluded 2026-09-03. FDA records classify OPS International Inc dba Olympia Pharmaceuticals 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.

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 — Aseptic processing areas are deficient rega rding t he syste m for monitoring environme

Aseptic processing areas are deficient rega rding t he syste m for monitoring environme nt al conditions. Specifica lly, (A) Th e firm's environmental moni tori ng proce dur e does n ot requ ire via bl e environmenta l monito ring during the initi al aseptic setup of t he (b) (4) filling line wit hin the[(o) (4) I - or during the initial asep ti c setu p of t he r 6 f-C4 Jl automated filling machine p os itioned unde r □ _ :, HEPA -filtered unid irection al airfl ow enclos ur e. Per SOP -009, Environmental Monitoring of the Controlled Production Areas, environ me ntal monitoring is not req uired to co mmen ce until as eptic connections setup activities h ave occurred. (1) On August 26, 2026, we observed operat or 1 l7xcr (D j pe rforming set-up of t he[ 6) (4 I for t he 0C 6 [(4n aut omat ed filling m ac hine (Eq uipment ID # lb><4l ) for t he filling of Ca lcium Chl or ide (Lot #H24A01-26). No environme nt al monit oring plates were prese nt wit hin the ISO 5 critical ar ea under th e :( 15) (4) J unidirectional airfl ow unit d ur ing t his setup activity. (2) According t o th e bat ch record fo r M ye r's Cocktail (Lot# G27A0S -26, Exp. 26 Nov 2026), equipment set-up of th e (b)

Observation 2 — Proced ures designed to preve nt microbiological conta mi na ti on of drug prod ucts p ur

Proced ures designed to preve nt microbiological conta mi na ti on of drug prod ucts p ur po rtin g to be sterile are n ot est ablished and followed. Specifica ll y, {A )Yo ur fi rm has not ad eq uately demonstrat ed th at [{6H 4) 1-sterili zed m ac hine[{ l:5)(4 )1 pa rts and accessories u se d in ase ptic filling maintain t heir sterile st at e dur ing t he esta bl is h ed [(o) (4) I post- sterilization hold ti me in a con tr olled, non-classified ar ea . Th e supp orti ng microbiological eva lua tio n consisted of swabbing pa rt surfaces and incubating sa mpl es in[(o) (4) I) medium af!bH 4I • for( oH 4) 1- {l )Yo ur firm h as not provided ad eq uate sc ientific ju sti fi ca ti on t hat t hese incubation conditi ons are su it able for recovering and detectin g microo rga nisms t ha t may be encountered if t he sterile b ar rier is compro mi sed d uring storage within the non-classified ar ea . {2)The p rov ided recorded asso ci at ed wi t h t he sa mplin g, in-hou se in cu bati on, an d results of the swab sa mples lacked t he foll ow ing criti cal in fo rm ati on: 111 Ill Ill Ill Actual in cu bati on tem pe rature Date and tim e sampl es we re placed in t he incu ba t or Date a

Observation 3 — Written production and process control procedures are not followed in the execution of

Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. Specifically, (B) Batch record review of Myer's Cocktail (Lot# G27A0S-26, Exp . 26 Nov 2026) revealed that equipment set-up of the (b) (4) filling line, located inside the ISO S~ in Suite (b) <4> began on 30 July 2026 at 08:01 and was completed by Sterile Tech : :~ at 08:06 on 30 July 2026 - a total elapsed time of five minutes. However, set-up encompassed installation of tl>H4I chambers: "---"( 15 )~~----------(4) where each require multiple set up steps. -For example, the [b} (40 chamber alone required the installation of multiple components, including the (15 ) (41 , and other associated parts. EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Mindy M Chou, I nves t igator 9/3/2026 OF THIS PAGE Michelle Lin, I nves t igator FORM FDA 483 (09/08) PREVIOUS EDmON OBSOLim! INSPECTION AL OBSERV ATIONS PAGE 4 of8 PAGES -- 4 of 9 -- DEPART!\fi:NT OF HEALTH Al~ HUM AN SERV ICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMB ER DATE(S)OF I NSPECTI ON 555 Winderley Place, Sui t e 200 8/20/2026 - 9/3/2026* Mai t

Observation 4 — Yo ur fi rm fa il ed t o est ablish adequate w ritten procedures for production and

Yo ur fi rm fa il ed t o est ablish adequate w ritten procedures for production and process controls designed t o ass ure t hat th e drug prod uct s have t he identi ty, st ren gt h, puri ty, and quality t hat th ey are purported or re prese nted t o po ssess . Specifica lly, t he w visual i ns pection qualificatio ~(b} (4~ u se d to qualify per so nnel pe rforming 100% visual inspection of injectable drug prod ucts are not ad equat ely chara ct erized or designed t o challenge insp ect ors' abil it y to detect particulates at or ne ar the th reshold of visu al det ectability. For example: (A) Yo ur firm h as not est ablished th e size or si ze ran ge of th e parti culate defect s co nt ained in th e qua li fi ca ti on units int ended t o challenge visual insp ect ors to d etect t he sm allest co nta minants p os sible fo r an inspector w ith 20/20 visio n. Alt hough~bH4! defect vials co nt aining particulates we re subm itte d for size char act erizatio n, th e analysis was performed u si ng th e particle- size distribu tio n m et hod d esc ribed in USP <429>, as docume nt ed in th e Ce rtifi ca t es of Anal ysis . The r es ul ti ng data do n ot esta blish t he si ze of the indivi

Observation 5 — The written stability program for drug products does not include reliable, meaningful and

The written stability program for drug products does not include reliable, meaningful and specific test methods. Specifically, your firm assigns a (b) (4) beyond-use date (BUD) to Sermorelin Acetate 0.9 mg/ml Injection based on your contract laboratory stability study. However, your firm failed to provide adequate demonstration that the analytical procedure can detect relevant degradation-related changes. Your method validation report for Sermorelin Acetate, approved on August 22, 2025, does not include a mass balance assessment to demonstrate that the analytical method can adequately account for the drug substance and its degradation products, supporting the method's stability-indicating capability and reliability.

Observation 6 — Separate or defined areas to prevent contamination or mix-ups are deficient regarding

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products. Specifically, (A) Your firm utilizes~ QA-access-controlled cabinets for the storage of sterilized machine 6 parts .,___.......__.,,_ and accessories. (b) (4) . During inspection ofthese cabinets (b) (4) components, including a stopper bowl that directly contacts product stoppers, were observed without sterilization-status labels. The components lacked information identifying the applicable 6 4 and sterilization date needed for personnel to determine whether the established sterile hold time had been exceeded . ____________________________ _ (B) Sterilization-status labels are generated by operators; however, the firm did not demonstrate a system for reconciling generated labels to the individual equipment parts associated with each sterilization cycle. EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Mindy M Chou, I nves t iga t or 9/3/2026 OF THIS PAGE Michelle Lin, I nves ti ga t or FORM FDA 483 (09/08) PAGE 6 of8 PAGES PREVIOUS EDmON OBSOLim! INSPECTIONAL OBSERVATIONS -- 6 of 9 -- DEPART!\fi:NT OF HEALTH Al~ H UMAN SERV ICES FOOD AND DRUG

Observation 7 — Component testing is deficient in that each component is not tested for conformity with

Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Sp ecifically, (A) SOP-035, Procurement, Receipt, and Inspection of Incoming Components and Materials, does not include a sampling plan specifying the number of containers to be sampled per shipment. According to the Senior Supply Chain Manager, [{6) (4) I sent from your [(6) (4) Jwarehouse to your facility for sampling. Additionally, no documentation exists for the sampling performed. (B) Your firm failed to perform a specific identity test that includes a methanol limit test on each container of each lot of ethyl alcohol used as a pharmaceutical ingredient. On May 12, 2025, your firm received !tiH•i bottles of :( 6) (4) JEthyl Alcohol ~bJ<4 ! Proof (Batch #1(~)]1 ) I) ; (6) (4) sampled, and 1 methanol limit testing was not performed. This lot was used in the production of T-105 Injection (Papaverine Hydrochloride 30 mg/ml; Phentolamine Mesylate 1 mg/ml; Alprostadil 0.01 mg/ml), Lot #G08A10-26, BUD 04 JUL 2027. (C) Your firm failed to test each container of each lot of glycerin, used as a pharmaceutical ingredient, for di

Observation 8 — Each component is not added to the batch by one person and verified by a second person ..

Each component is not added to the batch by one person and verified by a second person .. Specifically, a review of the batch record for Myer's Cocktail (Lot ~(~ )J1) I, Exp [(6) (4) I) revealed that ingredients were added between [ 6Jl2J) I on July 29, 2026, with no documented contemporaneous EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Mindy M Chou, I nves t iga t or 9/3/2026 OF THIS PAGE Michelle Lin, I nves t iga t or .,_ Ml n<fy M CMu .,Sig,-d&y: ~922: X ~;:~,...,•...,_,... FORM FDA 483 (09/08) S PAGE 7 PAGES PREVIOUS EDmON OB SOLim! IN PECTION AL OBSERV ATIONS of8 -- 7 of 9 -- Michelle UI ~~=~2002287276 X Date Signed: 09-03-202613 :1 4 :59 FORM FDA 483 (09/08) PAGE 8 of8 PAGES PREVIOUS EDmON OBSOLim! INSPECTIONAL OBSERVATIONS DEPART!\fi:NT OF HEALTH Al~ HUMAN SERVICES FOOD AND DRUG ADMINISTRATION D I STRI CT ADDR ESS ANO PHONE NUMB ER DATE(S) OF I NSPECTI ON 555 Wind erley Place, Sui te 200 8/20/2026 - 9/3/2026* Mait lan d , FL 32751 FEI NUMB ER 30097240 85(407)475 - 4700 Fax : ( 407) 475- 4768 NAME ANO TITLE OF IND IVIDUAL TO WH OM REPORT ISSUED Michael A. Bogar d , Direc t or of Pharmacy F IRM NAME STREET ADDRESS OPS I n ter na ti onal I nc d ba Olympia 6700 Conroy Rd Ste

OPS International Inc dba Olympia Pharmaceuticals’s FDA history

Argus HQ has recorded 1 total FDA action tied to OPS International Inc dba Olympia Pharmaceuticals: 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: 3009724085.
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.

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Full FDA history for OPS International Inc dba Olympia Pharmaceuticals

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). OPS International Inc dba Olympia Pharmaceuticals — FDA Form 483 Inspection, September 3, 2026 (8 Citations). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/ops-international-dba-olympia-pharmaceuticals-3009724085-2026-09-03

MLA

"OPS International Inc dba Olympia Pharmaceuticals — FDA Form 483 Inspection, September 3, 2026 (8 Citations)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/ops-international-dba-olympia-pharmaceuticals-3009724085-2026-09-03.

Chicago

Argus HQ Research. "OPS International Inc dba Olympia Pharmaceuticals — FDA Form 483 Inspection, September 3, 2026 (8 Citations)." Digital Empire Holdings LLC. Accessed October 12, 2026. https://argushq.ai/483/ops-international-dba-olympia-pharmaceuticals-3009724085-2026-09-03.

BibTeX

@misc{argushq_argushq_ai_483_ops_international_dba_olympia_pharmaceuticals_3009724085_2026_09_03_2026,
  title = {OPS International Inc dba Olympia Pharmaceuticals — FDA Form 483 Inspection, September 3, 2026 (8 Citations)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/ops-international-dba-olympia-pharmaceuticals-3009724085-2026-09-03},
  note = {Accessed: October 12, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗