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 Apollo Care 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 13 total FDA actions tied to Apollo Care 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.

Has Apollo Care LLC had other FDA inspection citations?

Yes. Argus HQ has recorded 13 total FDA actions tied to Apollo Care LLC, including 2 Form 483 inspection citations.

FDA Inspects Apollo Care LLC: Form 483 with 7 Citations (July 28, 2026)

Key facts

Firm	Apollo Care LLC
FEI / inspection ID	3013927023
Inspection end date	July 28, 2026
Citation count	7

Key takeaway: FDA inspected Apollo Care LLC in Montana and issued a Form 483 listing 7 inspectional observations following an inspection that concluded 2026-07-28. FDA records classify Apollo Care 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 — There is a failure of the quality control unit to secure their responsibility and

There is a failure of the quality control unit to secure their responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeli ng. and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. Specifically, A) You do not have procedures for documented review of retain samples . On 07/21/2026 and 07fl2rl026 the in spection team reviewed retain samples of Semaglutide Injection and Semaglutide with Glycine Injection drug product vials and observed approximately 59 vials across~ ots contained white particles of varying size and quantity, of which you were previously unaware. PLOYEE(S) NAME ANO TITLE (Prwit or Type) DATE ISS UED SEE REVERS Tyler M. Peterson, cso 07/28/2026 OF THIS PAGE Kelly M. Bromley, CSO Matthew M. Schuclanann, CSO "'6\'IOUll:»mON~ INSPECTIONAL OBSERVATIONS PAOll I Of I l'A .:I -- 1 of 9 -- - - - - - - - - - - - - - - DEPARTMENT OF ll&A.LTD AND HUMAN SERVICES FOOD AND DROO ADMINISTRATION 011.:., ........ , _,,_ ....,_.,,. 8050 Marshall Dr. , Suite 205 07/13/2026 - 07/28/20

Observation 2 — (Repeat) Your finn failed to establish and foll ow appropriate written procedures that

(Repeat) Your finn failed to establish and foll ow appropriate written procedures that are designed to prevent microbiological contam ination of drug products purporting to be sterile, and that in clude validation of all aseptic and steriliz.ation processes. SEE n EMPLOYEE(S) NAME ANO TITLE (Pmt or Type) DATEISSUEO eM'LO*\)SIGNA~ REVERSE -~y.1er M. Peterson, cso 07/28/2026 OF THIS PAGE pit. I ~ v .. .,~< 1A l.,,'°)b Kelly M. Broml ey, cso Matthew M. Schuclanann, cso V J101tM 'l>A •aJ (",., l'UVIOUI IJllf10H Oll.'lOUlT1I INSP£CTIONAL OBSERVATIONS P-'Oll l OI' I MOO -- 2 of 9 -- 0£PARTM £.NT OP ll f!AI..T it ANO IIUMA.N Sl!RVICf.S FOOD AND ORU O A.DIAINl$TltATIOlf 07/13/2026 - 07fllfl026 8050 Marshall Or.. ui te 20S ,...,._ l.cnc.\a. KS 6611 ◄ 3013927023 913-495•5 IOO ~,.,., ,,, 1,.11:1\a" •- - -TU ~ ----- - - James M. Krogman. CEO .. .._ . -- Apollo Care. LLC 3801 Mojave Ct Ste 101 u . • ,,..n::.. -- 503B Outsourcing Facility Colombia. MO 65202~042, USA Specifically• A) On 01/15/26 during aseptic filling operations for Semaglutide 4.5 mg/ml lnjecti on Lot AC-017 147 the particle counter used in the ISO 5 filling zone was paused during a manual intervention performed to adjust thel (

Observation 3 — (Repeat) There is a failure to thoroughly review any unexplained discrepancy, the failure

(Repeat) There is a failure to thoroughly review any unexplained discrepancy, 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, iI?ttC EMPLOYEE($) SIGNATURE EMPLOYEE (S) NAME ANO TTTlE (Pml « Type) DATE ISSUED SEE REVERSE "Tyler M. Peterson, cso 07 / 28 / 20 26 OF THIS PAGE , 0~o Kelly M. Bromley, cso 1/4 --7 ~ Matthew M. Schuckmann, cso .I"-r/ - 7 .;1: V l'OllM Pl>A 40 {.,,.., PIUlVIOUS fJ)fTl(JN ll80CU!JW INSPECTIONAL OBSERVATIONS PACJa J a, I HOltS -- 3 of 9 -- DEPARTMENT OF tcEALTH AND HUMAN S ERVlCES FOOD AND ORUO ADMll'I ISTRATION 07/13/2026- 07/l 8/l 026 8050 Marshall De., S uite 20S Leo!:xa, KS 662 I4 3 01 3927023 913-495-S 100 -AH:> o, IIOWllw. TO l'IOII REl'ORT-.ED James M. Krogman, CEO 3801 Moj ave Ct Ste 10 1 Apollo Care. LLC TYP£ ESTAIIU 81MEI/TINSPECTB> aTY, nA~Z1'C0ClE. ~ 503B Outsourcing Facility Co lumbia, MO 6S202-4042, USA A) Your visua1 inspection procedure INST00 t•Visual Inspection Revision 14 Effective Date 02/05/2026 is inadequate in that: i) Lot tolerance percent defect criteria is inadequate in that you a ll ow for less than or equal tJ(b)rf) of rejected un

Observation 4 — (Repeat) Your firm failed to perform operations withfo specifically defined areas of

(Repeat) Your firm failed to perform operations withfo specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas. Specifically, A) The design ofyour [( l:>) (4)1 sterile IV bag filling process lacks adequate aseptic and in-process material controls. This process was observed on 07/17/2026 during the compounding of Vancomycin 1 .5 g added to 250ml of 0. 9% Sodium Chloride (Lnjection For intravenous Use Only) Lot AC-017291 . i) Unfinished in-process Sodium Chloride JV bags were observed to be unnecessarily moved into and through the ISO 5 aseptic filling environment without aseptic manipulation, only to be removed back into the adjacent ISO 7 environment for intermittent in-process weight checks before being re introduced into the rso 5 hood. ii ) A support compounding operator was observed repeatedly handling both unfinished Sodium Chloride IV bags and finished Vancomycin in Sodium Chloride IV bags during in process weight checks, without adequate control over identification of finished and unfinished IV bags. E -Tv MPLO~EE(S ) SIG ATU RE ~ EMP LOYEE(S) NAM

Observation 5 — Each component is not tested for confonnity with all appropriate written specifications

Each component is not tested for confonnity with all appropriate written specifications for purity, strength, and quality. Specifically, A) You do not test all received containers of at-risk API raw material! ~ )('1-) J or potential contamination with l (6)(4) ~andi (6)(41 You release raw material I "(6)'(4) Tor compounding sterile human injectable drugs based upon review of the supplier CoA. You use~ (6)('4) '!lS a raw material in Semaglutide Injection products, including but not limited lot AC-017165. B) Your finn releases critical raw materials for use in compounding before a specific identity test. Perfonnance and review of identity testin g occur after quality release. You neither require batches to be made exclusively with materials after a completed identity test nor have a process to ensure that compounded lots are withheld from distribution until all component raw materials have a completed identity test. For example, you released semaglut id e' (b )( 4] ITN :I (6)(4) _J for use in EMPLOYEE(S) NAME AND TITI..E (Print or Type) DATEISSUEO SEE REVERSE Tyl e r M. Pe terso n, cso 07/28/2026 OF THIS PAGE ,,, Kelly M. Bromley , CSO L? ~h:,,,.-?/']~ - - Matthew M. Schuclanann, cso

Observation 6 — (Repeat) Buildings used in the manufacture, processing, packing, or holding of a drug do

(Repeat) Buildings used in the manufacture, processing, packing, or holding of a drug do not have the s uitable construction and location to facilitate cleaning, maintenance, and proper operations. Speci fi cally, A) On 07/13/2026 the in spection team observed you storing bagged steri le gowning and opened boxes of bagged components and materials used for aseptic compounding including sterile vials, vial stoppers, syringes, steril ( 'b )(4} b 4 bag, and IV bags of Sodium Chloride Injection USP in a warehouse constructed with exposed wood and 6 L1, -coated wall in sulation. On 07/ 17/2026, the inspection team observed a non-integral package of sterile coveralls in the facility's prep room amongst sterile garb staged for use in production. B) A textured wall pane l, approximately 4 ' x 18" in size, was observed on the wall in ISO 8 room Anteroomf(6 X4 lwhere all bulk formulation is performed.

Observation 7 — EM PLOY EE (S) NA ME AN D T l"QE (Print or T ype) DATE ISSUED Tyl e r M. Pet er son , cso

EM PLOY EE (S) NA ME AN D T l"QE (Print or T ype) DATE ISSUED Tyl e r M. Pet er son , cso 07/28/202 6 Kell y M. Bromley , cso Matthe w M. Sc h uckmann , CSO l'llEVIOUI ID!l10tlCl)3IOl.llT£ fNSPE CTJON AL OBSE RVATI ONS PAOI! 7 01'1 PAOl!S -- 7 of 9 -- l'OllM J'OA ◄O (-, _.,,...fJlrTD< ____,. INSP&CTIONAL OBSERVATIONS l'AOIU QI' I P\<JD DEPARTMENT OF HEALTH AND UUMAN SE RVICES FOOD ANO ORUO ADMINISTRATION 8050 Marshall Dr-~ Suite 205 07/ 13/2026 - 07/28/2026 Lenexa, KS 662 14 3 01 3927023 913-495•5100 James M. Krogman, CEO Apollo Care, LLC 3801 Mojave Ct Ste 101 CITY. STA'TE.zp COU'l11IV lVI'£ ESTMIJIH,W(r INSPECTED Columbia, MO 65202-4042, USA 5038 Outsourcing Facility Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 5038 because they (a) are not used to compou nd drug products that appear on the dru g shortage li st in effe.ct under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drug s ub stances for whfoh there is a clinical need. Specifically, Your facility compounded human drug products using semaglutide and tirzepatide bulk drug substance. SEE REVERSE OF THIS PAGE Ma

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.

Apollo Care LLC’s FDA history

Argus HQ has recorded 13 total FDA actions tied to Apollo Care LLC: 0 warning letters, 11 recalls, 0 approval records, and 2 Form 483 inspection citations.

Frequently asked questions

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 Apollo Care 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 13 total FDA actions tied to Apollo Care 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.
Has Apollo Care LLC had other FDA inspection citations?: Yes. Argus HQ has recorded 13 total FDA actions tied to Apollo Care LLC, including 2 Form 483 inspection citations.

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Full FDA history for Apollo Care 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). FDA Inspects Apollo Care LLC: Form 483 with 7 Citations (July 28, 2026). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/apollo-care-3013927023-2026-07-28

MLA

"FDA Inspects Apollo Care LLC: Form 483 with 7 Citations (July 28, 2026)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/apollo-care-3013927023-2026-07-28.

Chicago

Argus HQ Research. "FDA Inspects Apollo Care LLC: Form 483 with 7 Citations (July 28, 2026)." Digital Empire Holdings LLC. Accessed September 11, 2026. https://argushq.ai/483/apollo-care-3013927023-2026-07-28.

BibTeX

@misc{argushq_argushq_ai_483_apollo_care_3013927023_2026_07_28_2026,
  title = {FDA Inspects Apollo Care LLC: Form 483 with 7 Citations (July 28, 2026)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/apollo-care-3013927023-2026-07-28},
  note = {Accessed: September 11, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗